Provide expertise in the development, execution, and review of validation protocols. Develop and maintain a requalification schedule for facilities, equipment and processes based on a risk assessment, current industry "best practices," and regulatory requirements. Able to schedule staff to meet aggressive validation timelines. Responsible for the maintenance and implementation of the Validation Master Plan Schedules, including facility, equipment, and process requalification’s. Excellent working knowledge of cGMP requirements on validation methods and principals including ISPE, GAMP guidelines, and FDA, CFR Part 11 Electronic Records and Signatures requirements. Able to hire, mentor and train staff, and other resources as needed. Able to develop and write applicable validation documentation, including, but limited to URSs, FDSs, DOEs, FATs, IQs, OQs, PQs, and VQs from scratch/manuals, if not readily available. Able to handle multiple, complex projects and work independently.
Must be from Pharmaceutical Background
Must have Sterile injectable experience
Minimum 5 years in a management role in Validation in pharmaceutical industry.
Validation Master Plan Development / Update – VMP, CVMP
Develop and write applicable validation documentation, including, but limited to URSs, FDSs, DOEs, FATs, IQs, OQs, PQs, VQs
Validation of: Autoclaves, Depyrogenation Tunnels, Stability / Incubator / Refrigeration Chambers, Cleaning Equipment / Processes, Analytical Instruments, Facilities, Media Fills, Smoke Studies, Kaye Instrumentation
