Validation SpecialistApply Now
Location: Cambridge, Massachusetts 01752
Employment Type: Contract
Contract Length: 6+ Months to Start (Strong Likelihood of Extensions and/or Conversion to Permanent Full-Time Status)
Develop and maintain validation deliverables to assure compliance of IT systems to the relevant GxP standards e.g. 21 CFR Part 11, EU GMP Annex 11 and GAMP 5 to assure controls and testing meet industry regulations and systems are fit for purpose.
- Author and review qualification and validation documentation (Validation plan, URS, Business requirements, Test Scripts, Exception reports, Summary reports and associate applicable project deliverables as needed) in a timely manner ensuring compliance with GxP standards and industry expectations for IT compliance.
- Author IT change controls, System impact assessments, and deviations as needed.
- Work with business to develop requirements and specifications.
- Work with Vendor and BBI Project teams (Business analyst) to develop configuration requirements
- University degree or equivalent qualification, preferably in a life sciences subject.
- Experience of working with Quality Systems (CAPA, Dev, Change Control), GCP, GLP, GMP and PV.
- Experience with GAMP5 and Annex 11, Part 11: deliverables such as PQ, IQ, OQ, UAT, Val Plan, Val Summary Report, Trace matrix, Risk assessment, Change controls, periodic review.
Ovrille is responsible for full lifecycle recruiting for JVT’s clients across several industry verticals. He supports the Contract Recruiting team, and specializes in identifying temp (contractual) and temp-to-perm resources for JVT’s clients.
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