Validation Manager

Key Qualifications:

Extensive experience in the pharmaceutical industry, specifically with sterile injectable products.
At least 5 years of management experience in validation within the pharmaceutical sector.
Strong knowledge and hands-on experience in Validation Master Plan (VMP/CVMP) Development and updates.
Proven ability to create and maintain essential validation documentation, including URSs, FDSs, DOEs, FATs, IQs, OQs, PQs, and VQs.
Expertise in the validation of Autoclaves, Depyrogenation Tunnels, Stability Chambers, Cleaning Processes, Analytical Instruments, Facilities, and related systems.
Solid understanding of cGMP standards, FDA guidelines, ISPE and GAMP methodologies, and FDA CFR Part 11 compliance.