Our Client is seeking an IT Validation / Business Analyst based at our Cambridge site or remote. This validation/business analyst will be responsible for business analysis and validation of our GxP applications. Knowledge and experience with Veeva Quality Vault (QDocs, QMS, LMS), and Lab Information Management system (LIMS) or other lab systems is preferred. Deep understanding of the software development life cycle and computerized system validation principles.

• Knowledge of science – biology, chemistry, engineering, or related discipline is preferred, or its equivalent.

• Experience working in a GxP regulated environment, preferably in the biopharma space.

• Experience working with users from the quality, clinical, and regulatory domain.

• Experience working with Veeva Systems and SaaS applications.

• Experience working with LIMS or other lab systems.

• Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.

• Comprehensive understanding of the Software Development Life Cycle, GAMP 5 and regulatory agency requirements.

• Knowledge in following areas:

o Business analysis

o User requirements analysis

o System Development Life Cycle (SDLC) and validation requirements/documentation.

o Comprehensive understanding of GAMP 5 – Risk based approach to GxP system validation.

o Domain knowledge of Quality, Clinical, and Regulatory processes

o Veeva Systems Experience which includes Veeva Quality and Regulatory Vault.

o Lab Information Management Experience which includes validation of LIMS systems.

 Perform change management activities in support of system enhancements and user requirements.

 Author validation deliverables per SDLC

 Author Standard Operating Procedures and Work Instructions

• Strong ability to comprehend complex problems and apply knowledge to propose potential solutions.

• Analytical skills to be able to understand the needs of stakeholders and work out priorities.

• Strong written and oral communication skills as well as organizational skills.

• Demonstrated ability to work effectively under established guidelines and instructions.

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.