Prepare, review, and manage URS for sterile manufacturing systems including but not limited to; Aseptic filling lines, Isolators, Autoclaves and sterilization equipment, Depyrogenation tunnels, Cleanroom and HVAC systems, Critical utilities (Purified Water, Water for Injection, Clean Steam, Compressed Air), Environmental Monitoring systems, Laboratory and support equipment
Ensure URS complies with GMP, aseptic processing and regulatory expectations.
Coordinate with Engineering, Production, QA, QC, and vendors during URS finalization.
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