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)