Computer System Validation Lead

Are you a Computer System Validation Lead with experience working in all SaaS and/or all-cloud environments?

SQA is seeking an experienced Computer System Validation Lead to support our biopharmaceutical client in Cambridge, MA. The ideal candidate will have a proven track record of delivering quality documentation on time in a fast-paced environment. If you have a high level of attention to detail and flexibility to multi-task, we want to hear from you. Qualified candidates will be responsible for supporting the implementation and ongoing maintenance of various GxP systems under the umbrella of Scientific Applications (Research, Clinical, Regulatory, Safety, Pharmacology).

Consultants will be tasked with creating/updating validation documentation for software according to established procedures, including:

  • Master Validation Plans
  • Determining requirements acceptance criteria based on risk
  • Test protocols/test cases
  • Test reports and Master Validation reports
  • Traceability between requirements and test steps (Trace Matrix)
  • Must have 21 CFR Part 11 experience

Job ID:1903-5715

SQA is an equal opportunity employer and supports workforce diversity.