California Licensed CSV Lead

A company is looking for a CSV Validation Lead.

Key Responsibilities :

Define validation strategy for computerized systems and / or analytical instruments in GxP space

Create validation deliverables such as validation plans, test protocols, and traceability matrices

Participate in user review meetings and conduct risk assessments

Required Qualifications :

Bachelor's or Master's degree in Lifesciences or Computer Sciences

5+ years of experience with Computer Systems Validation

Strong knowledge of GxP requirements, GLP and GMP regulations, and 21 CFR part 11 requirements

Experience with laboratory or GxP systems validation like ELN, LIMS, QMS, etc