WE’RE NOT JUST ANOTHER
SOFTWARE COMPANY.
WE’RE A TEAM.

Role: Build & Release Manager

Location: Chennai 

Job Description: ValGenesis is looking for Software/Senior Software – Engineer for Chennai location with the below required skills.

Required Skills:   

• Design, build and configure applications to meet business process and application requirements
• Experience 10 to 15 years of ASP.NET with C# | Dot Net Framework 4.0 and above | SQL SERVER 2008 and above.
• Ability to understand in C#.Net, MVC, ASP.NET 4.0 framework, SQL and understand system requirements for building them
• Identify all the configuration items (CI’s) including environment variables and provide build with clean installation and uninstallation.
• Branch and merge code base without affecting trace and also minimize code size without duplication.
• Suggest managing interfaces in the application and bring them to the layer and abstract for use within the organization.
• Be hands on and independent in performing the build and test them for performance.
• Label / baseline the product against requirements and reproduce the earlier performance.
• Capable of building components and test them both independently and also in the product at a system level and suggest areas for improvements.
• Ability to identify product performance bottlenecks and distribute the product architecture layering and optimizing both application and system performance.
• Knowledge in configuration management tools and build management tools that would enable to provide periodic build and test them and identify defects earlier in the product life cycle management.
• Knowledge in Agile testing to discover defects early using automated unit testing framework, code review tools with both static and dynamic exaction and integrating into build / release
• Create staging environments with segregation of test, development and build areas with access to ensure that the source integrity and associated tests are performed and documented.
• Knowledge in installation of licensing methods will be an added advantage
• Ability to deploy the product and software patches in Cloud /Azure environments

Job Description

Review, analyze and evaluate business systems and user needs. Document requirements, define scope and objectives and develop system configurations to parallel overall business strategies.

Bachelor’s Degree in a related area and 2-4 years of experience in the field or in a related area. Familiar with validation and/or qualification concepts. Rely on experience and judgment to plan and accomplish goals.

Responsibilities:

Determine operational objectives by studying business functions; gathering information; evaluating output requirements and formats.

• Construct workflow charts and diagrams; studying system capabilities; writing specifications.
• Improve systems by studying current practices; designing modifications.
• Recommend controls by identifying problems; writing improved procedures.
• Maintain user confidence and protect operations by keeping information confidential
• Prepare technical reports by collecting, analyzing and summarizing information and trends
• Suggest changes to senior management using analytics to support your recommendations. Actively participate in the implementation of approved changes
• Conduct insightful, ad hoc analyses to investigate ongoing or one-time operational issues
• Provide knowledge transfer and training to customers on the systems to be implemented

Requirements:

• Bachelor’s Degree in appropriate field of study or equivalent work experience (computer science, systems development, industrial engineering).
• At least two years’ of experience working in a Life Sciences company (pharma, med device, biotech) in a role that involves validation and/or qualification activities
• Ability to impact operations and effect change without being confrontational
• Detail oriented, analytical and inquisitive
• Ability to work independently and with others
• Extremely organized with strong time-management skills

Business Analyst top skills & proficiencies:

• Software Design
• Analysis
• Teamwork
• Software Maintenance
• Process Improvement
• Big Picture Thinking
• Work Well Under Pressure
• Communication
• Problem Solving
• Critical Thinking
• Relationship Building

Designation: Manager Professional Services

Location: Munich, Bavaria, Germany

Domain: Life Science

Language: Native German, & English

The Manager in ValGenesis’ Professional Services will be responsible for managing the DACH/ Europe practice and coordinate the software implementation projects for our clients. Activities include team management, planning, resourcing and coordinating software projects for ValGenesis’ validation management software for Life Sciences companies, typically operating globally across multiple sites in North America, Europe and Asia. Hands-on team members providing various services such as strategic customer guidance, project management, business analysis and configuration support.

Required Skills:

· 10+ years of relevant team leadership and project management experience which includes managing of teams, projects, specifications, project milestones and associated deliverables

· 5-10 years of software implementation experience as a PM

· Experience in Life Sciences companies in validation, quality or related field

· Experience with validation of computer systems, equipment and other validation processes

· 5+ years’ experience working in an FDA regulated organization and knowledge of the validation lifecycle process

· Transparent and professional reporting of practice and project status with in-depth analysis of potential challenges and risks

· Ability to develop and grow a business practice, including recruitment and team member development

· Excellent verbal and written communication skills

· Strong familiarity with ISO, GLP, GCP and other related regulatory standards and guidelines

· Demonstrated leadership of cross-functional project teams and an ability to drive project plans to completion

· PMP certification preferred

Job Title: Technical Content Writer

Location: Toronto, ON

ValGenesis, Inc is a global organization with headquarters in South San Francisco, CA. Since 2004, ValGenesis has been advocating the need for an electronic system to manage the corporate validation process to enforce consistency, enhance compliance and standardize the corporate validation lifecycle processes. ValGenesis provides state of the art, enterprise software application that manages and automates the validation lifecycle process, enforces compliance, improves quality, and streamlines operations resulting in significant time and cost savings for companies operating in regulated environment including Biotech, Pharmaceutical, and Medical Devices industries.

We are disruptive and constantly evolving. We are passionate about our product, and we live for our customers. We have high expectations and a career at ValGenesis means challenging yourself to always be better.

ValGenesis is looking for a Technical Writer to join our product group in Toronto, ON. Product group is responsible for product documentation, user manual, as well as contextual help, FAQ, website content and user assistance content.

Roles and Responsibilities  

• Create Product marketing materials.
• Create product helpfiles for end users and system administrators.
• Experience in MadCap Flare is an advantage.
• Research, write, and ensure the accuracy of content that covers current and future releases of our product.
• Continuously improve documentation by incorporating feedback from customers and internal users.
• Review contents submitted for blogs by other internal resources (blogs, articles, product documentation, knowledge base, etc.)
• Ability to learn highly technical products quickly, using pre-release software and internal documentation.
• Ability to obtain information through research, interviews, and experimentation.
• Ability to work with geographically distributed team members and developers.
• Motivation and ability to be productive in a fast-paced, dynamic environment.
• Self-direction, flexibility, and an eagerness to learn. 

Minimum Requirements/Qualifications:

• B.S. in a relevant scientific field, such as biochemistry, molecular biology, Quality, Engineering, or cell biology.
• At least 3 years of technical writing experience, preferably in the software field and with experience in writing technical documentation.
• Knowledge of quality and regulatory compliance.

Job Title: Junior Application Engineer

Location: Toronto, ON

Rate: DOE 

Job Description: ValGenesis is looking for Junior Application Engineer in Toronto, ON location with the below required skills. 

Required Skills:   

• Design, build and configure applications to meet business process and application requirements
• Experience 2 to 3 years of ASP.NET with C# | Dot Net Framework 4.0 and above | SQL SERVER 2008 and above.
• Experience in MVC Pattern.
• Experience in using Web Services, WCF, LINQ, Ajax, Load Balance and Web API.
• Experience with Web Server IIS 7.0 and above is required.
• Knowledge/Experience in SSO integration using LDAP, ADFS, OKTA, PING.
• Knowledge/Experience in XSS, SSL, TLS, OWSAP standards.
• Knowledge/Experience in Xaml, WPF, CSS, Bootstrap.
• Knowledge/Experience in Scripting: Java Scripting, JQuery, AngularJS
• Knowledge/Experience in HTML, HTML5, XML, OOXML.
• Experience writing SQL queries and interpreting query execution plans.
• Knowledge in Agile Methodology.
• Good Oral and written communication skills.
• Good Team player and Self-initiated / motivated person.

 Position: Legal Counsel

Location: Toronto, Ontario, Canada

Job Description: As part of our rapid growth, we are looking for a smart, motivated, self-starter Legal Counsel to join our growing global legal team. As our first Legal Counsel in the company, you’ll have an awesome opportunity to use your legal expertise to have a big impact on a rapidly growing Product company.

Responsibilities:

As a Legal Counsel, you will serve as a legal point of contact and provide legal support to our teams globally (mainly in the US). Your responsibilities will include:

• Primary responsibility will be to support our sales force to draft, review, and negotiate a wide variety of commercial agreements (License Agreements, MSAs, NDAs, Vendor Contracts, Data Privacy and Partnership Agreements and others), and to ensure that all commercial agreements adequately protect the company’s interests, including cost and mitigate busines and reputation risks.
• Provide legal support and manage multiple deals simultaneously and support colleagues throughout the US and globally, with sound business and legal judgment while implementing and executing on company priorities.
• Manage the relationship with our external law firms globally and be knowledge in Europe and Asia legislations and participate on behalf of ValGenesis.
• Provide legal support for product development, including interpreting and translating technical concepts like privacy laws, GDPR and opining on legal risk
• Work with and support the Sales & Marketing Team with various Corporate Governance responsibilities including maintaining the document management system and database as an ongoing matter.
• Design and be a point of contact for Data Privacy program implementing effective privacy practices minimizing risks and ensure confidentiality for our business and its customers.
• Be abreast with the latest regulations and legislations and advise the organization senior management on processes and security to establish governance for an effective privacy program.
• Serves in a leadership role for privacy compliance.
• Establishes, with the information security officer, an ongoing process to track, investigate and report inappropriate access and disclosure of personal or sensitive data if any.
• Performs or oversees initial and periodic information privacy risk assessment, mitigation and remediation.
• Report on ongoing compliance monitoring activities in coordination with the organization’s other compliance and operational assessment functions.
• Oversees, develops and delivers initial and ongoing privacy training to the workforce.
• Participates in the development, implementation, and ongoing compliance monitoring of all business associates and business associate agreements, to ensure all privacy concerns, requirements, and responsibilities are addressed.
• Manages all required Incident / security breach determination and notification processes in line with EU regulations and GDPR norms.
• Maintains current knowledge of applicable federal and state privacy laws and accreditation standards.

Requirements:

• 3+ years of extensive and broad commercial legal experience in a law firm or in-house company, experience working in a global high-tech company, preferably Product base firms
• Doctor of Jurisprudence (JD) degree from an accredited law school required and bar membership in at least one U.S. jurisdiction
• Excellent organizational skills with the ability to manage several simultaneous projects under tight deadlines
• Strong experience in drafting, negotiating, and managing a wide variety of commercial agreements relevant to the company operations, including professional services agreements, business agreements, intellectual property agreements, data privacy laws and EU GDPR regulations.
• Ability to work independently as a legal advisor to the company but having with full recognition of areas of limitations and need for support
• Ability to work independently with minimal supervision, motivated self-starter
• Knowledge in Life sciences regulatory domain is preferred.

Advantages:

• Experience as an in-house at a successful, high-growth Product base company
• Ability to handle complex business and legal issues in a fast-paced, agile and evolving technology-driven business environment
• Resilient, positive attitude. We need someone willing to adapt to change and able to function smoothly in a very fast paced environment.
• High sense of urgency with proactive rather than reactive attitude.
• High attention to detail and high degree of integrity in work product a must.
• Ability to effectively communicate with senior management, in writing and verbally.
• Ability to read, analyze, and interpret complex documents.
• Ability to respond effectively to the most sensitive inquiries or complaints.
• Ability to make effective presentations on legal issues to the board of directors, senior management, and sales groups.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.

Position: Manager – Quality

Location: Toronto, Ontario, Canada

Job description

ValGenesis is looking for highly diligent candidates with excellent attention to detail for the role of Quality Manager. Responsible for overall development, implementation, and maintenance of the organization’s Quality Management System (QMS).

Required Skills:

• Should have eye for details and diligent in work performed with follow-up to ensure that work is performed right first time.
• Should have high interpersonal skills to motivate and move along within the QA team and with the other teams in the organization.
• Ability to interact with customers with clear responses to resolve the findings. (Knowledge in GAMP 5, ISO 9001, 27001, ITIL, GDPR and SSAE 16 is preferred)
• Elucidate requirements from user stories and use case scenarios bringing out behaviour orientation and derive non-functional requirements and associated specifications.
• Create training plan, role-based training matrix, competency assessment and maintenance of training records in line with the Life- science’s needs.
• Compliance of product and project requirements with customer feedback and effective resolutions.
• QMS development, periodic review, revision, and implementation of SOPs / procedures with formal change, impact assessment with continual improvements.
• Knowledge in Agile and SDLC models and verify deliverables flawlessly from requirements to release to customers.
• Excellent knowledge in determining root causes with Corrective and preventive actions.
• Excellent written and verbal communication with the ability to view/ perceive from the customers viewpoint.
• Ability to perform risk identification using tools like FMEA with mitigation strategies including risk control methods/ measures. Manage risk assessment with organization assets and associated control and response plans.
• Ability to handle deviations with CAPA, incident management, Non-conformance reports and audits.
• Ability to arrive at specifications for product, service both qualitative and quantitative data.
• Be hands on in terms of creating QC plans, Project Plans, Configuration Management Plans, Validation protocols and monitor them to closure. (Knowledge in Life sciences specific terminologies is preferred).
• Ability to create performance baselines and estimates based on project / product data.
• Understanding customer expectations of and needs from a product with adherence to legal and regulatory standards.
• Early warning and reporting to top management on quality issues. Knowledge in statistical analysis and inferences is preferred.
• Prefer knowledge in life sciences domain with security and basic programming languages / scripts

 Qualifications:

• Degree in Engineering and/or Business Administration and/or Life-sciences relevant domain is preferred.
• Quality control and other relevant certification is preferred.
• ISO Lead auditor certificates for 9001 and 27001.

Position: Business Analyst

Location:  Munich, Germany

Job Description:

Review, analyze and evaluate business systems and user needs. Document requirements, define scope and objectives and develop system configurations to parallel overall business strategies.

Bachelor’s Degree in a related area and 2-4 years of experience in the field or in a related area. Familiar with validation and/or qualification concepts. Rely on experience and judgment to plan and accomplish goals.

Responsibilities: 

• Determine operational objectives by studying business functions; gathering information; evaluating output requirements and formats.
• Construct workflow charts and diagrams; studying system capabilities; writing specifications.
• Improve systems by studying current practices; designing modifications.
• Recommend controls by identifying problems; writing improved procedures.
• Maintain user confidence and protect operations by keeping information confidential
• Prepare technical reports by collecting, analyzing and summarizing information and trends
• Suggest changes to senior management using analytics to support your recommendations. Actively participate in the implementation of approved changes
• Conduct insightful, ad hoc analyses to investigate ongoing or one-time operational issues
• Provide knowledge transfer and training to customers on the systems to be implemented

Requirements:

• Bachelor’s Degree in appropriate field of study or equivalent work experience (computer science, systems development, industrial engineering).
• At least two years’ of experience working in a Life Sciences company (pharma, med device, biotech) in a role that involves validation and/or qualification activities
• Ability to impact operations and effect change without being confrontational
• Detail oriented, analytical and inquisitive
• Ability to work independently and with others
• Extremely organized with strong time-management skills

Business Analyst top skills & proficiencies:

• Software Design
• Analysis
• Teamwork
• Software Maintenance
• Process Improvement
• Big Picture Thinking
• Work Well Under Pressure
• Communication
• Problem Solving
• Critical Thinking
• Relationship Building

Position: Legal Counsel

Location: Tampa, FL / South San Francisco, California

Job Description: As part of our rapid growth, we are looking for a smart, motivated, self-starter Legal Counsel to join our growing global legal team. As our first Legal Counsel in the company, you’ll have an awesome opportunity to use your legal expertise to have a big impact on a rapidly growing Product company.

Responsibilities:

As a Legal Counsel, you will serve as a legal point of contact and provide legal support to our teams globally (mainly in the US). Your responsibilities will include:

• Primary responsibility will be to support our sales force to draft, review, and negotiate a wide variety of commercial agreements (License Agreements, MSAs, NDAs, Vendor Contracts, Data Privacy and Partnership Agreements and others), and to ensure that all commercial agreements adequately protect the company’s interests, including cost and mitigate busines and reputation risks.
• Provide legal support and manage multiple deals simultaneously and support colleagues throughout the US and globally, with sound business and legal judgment while implementing and executing on company priorities.
• Manage the relationship with our external law firms globally and be knowledge in Europe and Asia legislations and participate on behalf of ValGenesis.
• Provide legal support for product development, including interpreting and translating technical concepts like privacy laws, GDPR and opining on legal risk
• Work with and support the Sales & Marketing Team with various Corporate Governance responsibilities including maintaining the document management system and database as an ongoing matter.
• Design and be a point of contact for Data Privacy program implementing effective privacy practices minimizing risks and ensure confidentiality for our business and its customers.
• Be abreast with the latest regulations and legislations and advise the organization senior management on processes and security to establish governance for an effective privacy program.
• Serves in a leadership role for privacy compliance.
• Establishes, with the information security officer, an ongoing process to track, investigate and report inappropriate access and disclosure of personal or sensitive data if any.
• Performs or oversees initial and periodic information privacy risk assessment, mitigation and remediation.
• Report on ongoing compliance monitoring activities in coordination with the organization’s other compliance and operational assessment functions.
• Oversees, develops and delivers initial and ongoing privacy training to the workforce.
• Participates in the development, implementation, and ongoing compliance monitoring of all business associates and business associate agreements, to ensure all privacy concerns, requirements, and responsibilities are addressed.
• Manages all required Incident / security breach determination and notification processes in line with EU regulations and GDPR norms.
• Maintains current knowledge of applicable federal and state privacy laws and accreditation standards.

Requirements:

• 3+ years of extensive and broad commercial legal experience in a law firm or in-house company, experience working in a global high-tech company, preferably Product base firms
• Doctor of Jurisprudence (JD) degree from an accredited law school required and bar membership in at least one U.S. jurisdiction
• Excellent organizational skills with the ability to manage several simultaneous projects under tight deadlines
• Strong experience in drafting, negotiating, and managing a wide variety of commercial agreements relevant to the company operations, including professional services agreements, business agreements, intellectual property agreements, data privacy laws and EU GDPR regulations.
• Ability to work independently as a legal advisor to the company but having with full recognition of areas of limitations and need for support
• Ability to work independently with minimal supervision, motivated self-starter
• Knowledge in Life sciences regulatory domain is preferred.

Advantages:

• Experience as an in-house at a successful, high-growth Product base company
• Ability to handle complex business and legal issues in a fast-paced, agile and evolving technology-driven business environment
• Resilient, positive attitude. We need someone willing to adapt to change and able to function smoothly in a very fast paced environment.
• High sense of urgency with proactive rather than reactive attitude.
• High attention to detail and high degree of integrity in work product a must.
• Ability to effectively communicate with senior management, in writing and verbally.
• Ability to read, analyze, and interpret complex documents.
• Ability to respond effectively to the most sensitive inquiries or complaints.
• Ability to make effective presentations on legal issues to the board of directors, senior management, and sales groups.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.

Location: Munich, Bavaria, Germany

Domain: Life Science

Language: Native German, & English

The Manager in ValGenesis’ Professional Services will be responsible for managing the DACH/ Europe practice and coordinate the software implementation projects for our clients. Activities include team management, planning, resourcing and coordinating software projects for ValGenesis’ validation management software for Life Sciences companies, typically operating globally across multiple sites in North America, Europe and Asia. Hands-on team members providing various services such as strategic customer guidance, project management, business analysis and configuration support.

Required Skills:

• 10+ years of relevant team leadership and project management experience which includes managing of teams, projects, specifications, project milestones and associated deliverable’s
• 5-10 years of software implementation experience as a PM
• Experience in Life Sciences companies in validation, quality or related field
• Experience with validation of computer systems, equipment and other validation processes
• 5+ years’ experience working in an FDA regulated organization and knowledge of the validation lifecycle process
• Transparent and professional reporting of practice and project status with in-depth analysis of potential challenges and risks
• Ability to develop and grow a business practice, including recruitment and team member development
• Excellent verbal and written communication skills
• Strong familiarity with ISO, GLP, GCP and other related regulatory standards and guidelines
• Demonstrated leadership of cross-functional project teams and an ability to drive project plans to completion
• PMP certification preferred

Job Description: ValGenesis is looking for Validation Engineer for Tampa, FL location with the below required skills.

Required Skills:   

• 2 – 5 years in Computer System Validation or Testing Experience in Life science/Pharmaceutical domain is mandatory
• Review of Requirement specifications like URS, FRS, SRS etc.
• Authoring and Execution of validation protocols like OQ and PQ
• Involve in Validation Planning and Reporting
• To support Internal and external Audits
• GDP compliance
• Knowledge of Software validation process and testing methodologies
• Good knowledge of GAMP 5, 21CFR Part 11, Annex 11
• Good interpersonal and communication skills
• Team player
• Good time-management skills

About us:

ValGenesis is a global organization with headquarters in Fremont, CA. Since 2004, ValGenesis, Inc. has advocating the need for an electronic system to manage the corporate validation process to enforce consistency, enhance compliance and standardize the corporate validation process. ValGenesis is the first enterprise software solution to manage the corporate validation process 100% electronically. PDA (Parenteral Drug Association) has selected ValGenesis as a New Innovative technology to manage the validation process 100% electronically. Our headquarters is based in Fremont, CA, USA with development center in TICEL Bio Park, Taramani, Chennai, Tamil Nadu. Most of our clients are based in US and Europe

Job Description: ValGenesis is looking for Validation Engineer for Toronto, ON location with the below required skills.

Required Skills:   

• 2 – 5 years in Computer System Validation or Testing Experience in Life science/Pharmaceutical domain is mandatory
• Review of Requirement specifications like URS, FRS, SRS etc.
• Authoring and Execution of validation protocols like OQ and PQ
• Involve in Validation Planning and Reporting
• To support Internal and external Audits
• GDP compliance
• Knowledge of Software validation process and testing methodologies
• Good knowledge of GAMP 5, 21CFR Part 11, Annex 11
• Good interpersonal and communication skills
• Team player
• Good time-management skills

About us:

ValGenesis is a global organization with headquarters in Fremont, CA. Since 2004, ValGenesis, Inc. has advocating the need for an electronic system to manage the corporate validation process to enforce consistency, enhance compliance and standardize the corporate validation process. ValGenesis is the first enterprise software solution to manage the corporate validation process 100% electronically. PDA (Parenteral Drug Association) has selected ValGenesis as a New Innovative technology to manage the validation process 100% electronically. Our headquarters is based in Fremont, CA, USA with development center in TICEL Bio Park, Taramani, Chennai, Tamil Nadu. Most of our clients are based in US and Europe

Position: Manager – Quality

Location: Chennai

Job description

ValGenesis is looking for highly diligent candidates with excellent attention to detail for the role of Quality Manager. Responsible for overall development, implementation, and maintenance of the organization’s Quality Management System (QMS).

Required Skills:

• Should have eye for details and diligent in work performed with follow-up to ensure that work is performed right first time.
• Should have high interpersonal skills to motivate and move along within the QA team and with the other teams in the organization.
• Ability to interact with customers with clear responses to resolve the findings. (Knowledge in GAMP 5, ISO 9001, 27001, ITIL, GDPR and SSAE 16 is preferred)
• Elucidate requirements from user stories and use case scenarios bringing out behaviour orientation and derive non-functional requirements and associated specifications.
• Create training plan, role-based training matrix, competency assessment and maintenance of training records in line with the Life- science’s needs.
• Compliance of product and project requirements with customer feedback and effective resolutions.
• QMS development, periodic review, revision, and implementation of SOPs / procedures with formal change, impact assessment with continual improvements.
• Knowledge in Agile and SDLC models and verify deliverables flawlessly from requirements to release to customers.
• Excellent knowledge in determining root causes with Corrective and preventive actions.
• Excellent written and verbal communication with the ability to view/ perceive from the customers viewpoint.
• Ability to perform risk identification using tools like FMEA with mitigation strategies including risk control methods/ measures. Manage risk assessment with organization assets and associated control and response plans.
• Ability to handle deviations with CAPA, incident management, Non-conformance reports and audits.
• Ability to arrive at specifications for product, service both qualitative and quantitative data.
• Be hands on in terms of creating QC plans, Project Plans, Configuration Management Plans, Validation protocols and monitor them to closure. (Knowledge in Life sciences specific terminologies is preferred).
• Ability to create performance baselines and estimates based on project / product data.
• Understanding customer expectations of and needs from a product with adherence to legal and regulatory standards.
• Early warning and reporting to top management on quality issues. Knowledge in statistical analysis and inferences is preferred.
• Prefer knowledge in life sciences domain with security and basic programming languages / scripts

 Qualifications:

• Degree in Engineering and/or Business Administration and/or Life-sciences relevant domain is preferred.
• Quality control and other relevant certification is preferred.
• ISO Lead auditor certificates for 9001 and 27001.

Position: Manager – Quality

Location: Tampa, FL 

Job description

ValGenesis is looking for highly diligent candidates with excellent attention to detail for the role of Quality Manager. Responsible for overall development, implementation, and maintenance of the organization’s Quality Management System (QMS).

Required Skills:

• Should have eye for details and diligent in work performed with follow-up to ensure that work is performed right first time.
• Should have high interpersonal skills to motivate and move along within the QA team and with the other teams in the organization.
• Ability to interact with customers with clear responses to resolve the findings. (Knowledge in GAMP 5, ISO 9001, 27001, ITIL, GDPR and SSAE 16 is preferred)
• Elucidate requirements from user stories and use case scenarios bringing out behaviour orientation and derive non-functional requirements and associated specifications.
• Create training plan, role-based training matrix, competency assessment and maintenance of training records in line with the Life- science’s needs.
• Compliance of product and project requirements with customer feedback and effective resolutions.
• QMS development, periodic review, revision, and implementation of SOPs / procedures with formal change, impact assessment with continual improvements.
• Knowledge in Agile and SDLC models and verify deliverables flawlessly from requirements to release to customers.
• Excellent knowledge in determining root causes with Corrective and preventive actions.
• Excellent written and verbal communication with the ability to view/ perceive from the customers viewpoint.
• Ability to perform risk identification using tools like FMEA with mitigation strategies including risk control methods/ measures. Manage risk assessment with organization assets and associated control and response plans.
• Ability to handle deviations with CAPA, incident management, Non-conformance reports and audits.
• Ability to arrive at specifications for product, service both qualitative and quantitative data.
• Be hands on in terms of creating QC plans, Project Plans, Configuration Management Plans, Validation protocols and monitor them to closure. (Knowledge in Life sciences specific terminologies is preferred).
• Ability to create performance baselines and estimates based on project / product data.
• Understanding customer expectations of and needs from a product with adherence to legal and regulatory standards.
• Early warning and reporting to top management on quality issues. Knowledge in statistical analysis and inferences is preferred.
• Prefer knowledge in life sciences domain with security and basic programming languages / scripts 

Qualifications:

• Degree in Engineering and/or Business Administration and/or Life-sciences relevant domain is preferred.
• Quality control and other relevant certification is preferred.
• ISO Lead auditor certificates for 9001 and 27001.

Job Description:

ValGenesis is looking for multiple Sales Directors across US, Europe and Canada, Validation Lifecycle Management System (VLMS) is a flagship product of ValGenesis Inc. and is the first enterprise software solution to manage the corporate validation lifecycle process 100% electronically. ValGenesis VLMS is the system of record and standard for all types of validation processes for several global regulated life science companies including 10 of the top 15 global Pharma and Biotech companies. ValGenesis is becoming a de facto standard for paperless Validation across the life science industry.

The Sales Director will be tasked with sales performance goals to maximize the revenue, profitability and market share of ValGenesis by sales execution of a full Suite of Validation Lifecycle Software products to Life Science accounts. You will be integral in identifying opportunities and activities necessary to increase ValGenesis footprint in the Life Science industry.

Responsibilities include identification of target companies, in-depth qualification of prospect business needs, presentation of ValGenesis unique value proposition and industry leadership for each unique opportunity, negotiation of business terms, and execution of the required agreements and documentation of the process in the ValGenesis sales management systems.

Essential Functions:

• Direct major-account sales for ValGenesis products and services, while developing a credible, advisory relationship with targeted accounts
• Understand the goals and challenges of each account, specifically related to Validation Lifecycle Management
• Work closely with Marketing, Presales and Management to drive and manage the sales plan
• Identify, establish, report and maintain opportunity pipeline and forecast

Requirements:

• 5 plus recent years selling complex application software solutions
• Background selling Enterprise Applications Sales to Life Science companies required
• Clear understanding of the Sales process, product, and service value propositions
• Capability to leverage your relationships and your knowledge of the territory in which you are selling
• Consistent track record for developing new business and managing a complex sales cycle, from generating leads to closing deals
• Successful track record of management of ongoing client relationships
• Experience with QMS, ECM, Validation and PLM solutions a plus
• Highly motivated professional with excellent communication and interpersonal skills
• Excellent written and verbal communication skills
• Able to work independently in a fast-paced environment
• Knowledge of Zoho or other CRM systems

Education:

• Bachelors degree (BA or BS)

Travel:

• 40% to 60% travel

Compensation:

• Attractive base salary
• Participation in commission plan and bonus
• Competitive benefits package including Health, Dental and 401k Plan
• Generous Pre IPO Stock Options

Preferred Locations:

• Tampa, FL
• San Francisco, CA
• Dublin, Ireland
• Munich, Germany
• Toronto, ON

Review, analyze and evaluate business systems and user needs. Document requirements, define scope and objectives and develop system configurations to parallel overall business strategies.

Bachelor’s Degree in a related area and 2-4 years of experience in the field or in a related area. Familiar with validation and/or qualification concepts. Rely on experience and judgment to plan and accomplish goals.

Responsibilities:

• Determine operational objectives by studying business functions; gathering information; evaluating output requirements and formats.
• Construct workflow charts and diagrams; studying system capabilities; writing specifications.
• Improve systems by studying current practices; designing modifications.
• Recommend controls by identifying problems; writing improved procedures.
• Maintain user confidence and protect operations by keeping information confidential
• Prepare technical reports by collecting, analyzing and summarizing information and trends
• Suggest changes to senior management using analytics to support your recommendations. Actively participate in the implementation of approved changes
• Conduct insightful, ad hoc analyses to investigate ongoing or one-time operational issues
• Provide knowledge transfer and training to customers on the systems to be implemented

Requirements:

• Bachelor’s Degree in appropriate field of study or equivalent work experience (computer science, systems development, industrial engineering).
• Ability to impact operations and effect change without being confrontational
• Detail oriented, analytical and inquisitive
• Ability to work independently and with others
• Extremely organized with strong time-management skills

Business Analyst top skills & proficiencies:

• Software Design
• Analysis
• Teamwork
• Software Maintenance
• Process Improvement
• Big Picture Thinking
• Work Well Under Pressure
• Communication
• Problem Solving
• Critical Thinking
• Relationship Building

Position: Project Lead / Manager Professional Services
Experience: Above 10 Years
Email: hr@valgenesis.com
Work Location: Munich, Germany
Domain: Life Sciences

The Manager in ValGenesis’ Professional Services will be responsible for managing the DACH/ Europe practice and coordinate the software implementation projects for our clients. Activities include team management, planning, resourcing and coordinating software projects for ValGenesis’ validation management software for Life Sciences companies, typically operating globally across multiple sites in North America, Europe and Asia. Hands-on team members providing various services such as strategic customer guidance, project management, business analysis and configuration support.

Required Skills:

• 10+ years of relevant team leadership and project management experience which includes managing of teams, projects, specifications, project milestones and associated deliverables
• 5+ years’ experience working in an FDA regulated organization and knowledge of the validation lifecycle process
• Transparent and professional reporting of practice and project status with in-depth analysis of potential challenges and risks
• Ability to develop and grow a business practice, including recruitment and team member development
• Excellent verbal and written communication skills in German language
• Strong familiarity with ISO, GLP, GCP and other related regulatory standards and guidelines
• Demonstrated leadership of cross-functional project teams and an ability to drive project plans to completion
• PMP certification preferred

Position: Project Manager / Business Analyst
Experience: 2-4 Years
Email: hr@valgenesis.com
Work Location: Munich, Germany
Domain: Life Sciences

Review, analyze and evaluate business systems and user needs. Document requirements define scope and objectives and develop system configurations to parallel overall business strategies. Bachelor’s Degree in a related area, 2-4 years of experience in the field or in a related area is a plus. Familiar with validation and/or qualification concepts. Rely on experience and judgment to plan and accomplish goals.

Responsibilities:

• Determine operational objectives by studying business functions; gathering information; evaluating output requirements and formats.

• Construct workflow charts and diagrams; studying system capabilities; writing specifications.
• Improve systems by studying current practices; designing modifications.
• Recommend controls by identifying problems; writing improved procedures.
• Maintain user confidence and protect operations by keeping information confidential
• Prepare technical reports by collecting, analyzing and summarizing information and trends
• Suggest changes to senior management using analytics to support your recommendations. Actively participate in the implementation of approved changes
• Conduct insightful, ad hoc analyses to investigate ongoing or one-time operational issues
• Provide knowledge transfer and training to customers on the systems to be implemented

Required Skills:

• Bachelor s Degree in appropriate field of study or equivalent work experience (computer science, systems development, industrial engineering).
• Ability to impact operations and effect change without being confrontational
• Detail oriented, analytical and inquisitive
• Ability to work independently and with others
• Extremely organized with strong time-management skills
• Excellent verbal and written communication skills in German language

Business Analyst top skills & proficiencies:

• Software Design
• Analysis
• Teamwork
• Software Maintenance
• Process Improvement
• Big Picture Thinking
• Work Well Under Pressure
• Communication
• Problem Solving
• Critical Thinking
• Relationship Building

Position: UI Developer
Experience: 4 – 8 Years
Email: hr@valgenesis.com
Work Location: Chennai

Mandatory Skillset: HTML5, CSS3, Bootstrap 4.0+, Angular 4+, JavaScript, jQuery, WordPress (Working Knowledge), PHP (Working Knowledge), Microsoft .NET (DOM Support Knowledge)

Responsibilities

• Develop new user-interface features in HTML/ PHP/ WordPress or DOM support for .NET projects
• Build reusable code and libraries for future use
• Hand-code Angular4+ requirements and JavaScript along with jQuery customization
• Ensure the technical feasibility of UI/UX designs
• Optimize application for maximum speed and scalability
• Assure that all user input is validated before submitting to back-end
• Collaborate with other team members, developers and stakeholders for smooth product roll-outs and patch releases.

Technical Skill:

• 4+ Years of work experience in UI Development field.
• Excellent Knowledge of HTML5 and CSS3
• Excellent knowledge of Angular 4+
• Knowledge of UI Layouts, bootstrap and CSS Grid System
• Should be well-versed in JavaScript and jQuery coding
• Good Communication skills and the ability to work well in teams
• Must have ability to analyze bugs and proving proper solutions to resolve it.
• Proficient understanding of cross-browser and cross-platform compatibility issues and ways to work around them.
• Proficient understanding of code versioning tools, such as {{Git / Mercurial / SVN}}
• Good understanding of SEO principles and ensuring that application will adhere to them.

Position: Software Engineer/ Sr. Software Engineer/ Module Lead
Experience: 5 – 10 Years
Educational Qualification: BE / BTech in Computer Science/ MCA
Email: hr@valgenesis.com
Work Location: Chennai

Required Skills:

• ASP.NET with C# | Dot Net Framework 4.0 and above | SQL SERVER 2008 and above
• Experience in MVC Pattern
• Experience in Web Services, WCF, LINQ, Ajax, Load Balance and Web API
• Knowledge/Experience in SSO integration using LDAP, ADFS, OKTA, PING
• Knowledge/Experience in XSS, SSL, TLS, OWSAP standards
• Knowledge/Experience in Xaml, WPF, CSS, Bootstrap
• Knowledge/Experience in Scripting: Java Scripting, JQuery, AngularJS
• Knowledge/Experience in HTML, HTML5, XML , OOXML
• Knowledge in Serializations Jason is an advantage
• Knowledge/Experience in using TFS / SVN
• Knowledge/Experience in DevExpress report, SSRS, crystal report, BI Components
• Knowledge/Experience using 3rd party Control: Infragistic, Far Point
• Experience with Web Server IIS 7.0 and above is required
• Knowledge/Experience in VSTS, QTP is preferable
• Experience writing SQL queries and interpreting query execution plans
• Knowledge in Agile Methodology
• Good Oral and written communication skills