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CSV Validation Lead
Job Summary
A company is looking for a CSV Validation Lead.
Key Responsibilities
- Define validation strategy for computerized systems and analytical instruments in GxP space
- Create validation deliverables such as validation plans, test protocols, and traceability matrices
- Conduct user review meetings and lead discussions with Quality Assurance and Compliance groups
Required Qualifications
- Bachelor's or Master's degree in Life Sciences or Computer Sciences
- 10+ years of experience with Computer Systems Validation in the pharmaceutical industry
- Strong knowledge of GxP requirements, GLP, GMP regulations, and 21 CFR part 11 requirements
- Experience with laboratory or GxP systems validation (e.g., ELN, LIMS, QMS)
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COMPLETE JOB DESCRIPTION
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