Provide expertise in the review/approval of validation protocols and reports but not limited to steam sterilization, environmental monitoring, clean utilities, process equipment, temperature mappings, cleaning validation, process validation etc. Ensure the compliance of requalification schedule for facilities, equipment and processes based on a risk assessment, current industry "best practices," and regulatory requirements. Responsible for ensuring the compliance state of 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 mentor and train staff, and other resources as needed. Able to guide the validation team for developing 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.
Additional Responsibilities:
Other duties as assigned.
Education and Experience:
Bachelor's Degree from a four-year accredited college or university with Major in Pharmacy, Chemistry or Microbiology or equivalent work experience in the pharmaceutical industry for at least 8 years. Sterile injectable experience required.
Must be from a Pharmaceutical Background
*Sterile Liquid Injectable Experience - Validation execution of Autoclaves, Tunnels, Filtration systems, Filling Machines, Lyophilizers, SIP/CIP, Part washers, HVAC etc.)
*Clean Utility Qualification (Purified water, Water for Injection, Pure Steam, etc.)