Katalyst Healthcares and Life Sciences
Responsibilities:
Execute validation activities across the full equipment lifecycle (FAT, SAT, Commissioning, DQ, IQ, OQ, PQ). Apply GAMP 5 methodology in a GMP-regulated environment. Support Greenfield project initiatives and equipment startup. Handle deviations, change controls, and validation deliverables. Collaborate with cross-functional teams including QA, Engineering, and Manufacturing. Requirements:
Prior experience with fill-finish equipment including syringe assembly, serialization lines, and cartoners. Strong understanding of GAMP 5 and validation lifecycle documentation. Hands-on exposure to Greenfield projects. Excellent communication and documentation skills. Experience managing deviations, CAPAs, and change controls.
Execute validation activities across the full equipment lifecycle (FAT, SAT, Commissioning, DQ, IQ, OQ, PQ). Apply GAMP 5 methodology in a GMP-regulated environment. Support Greenfield project initiatives and equipment startup. Handle deviations, change controls, and validation deliverables. Collaborate with cross-functional teams including QA, Engineering, and Manufacturing. Requirements:
Prior experience with fill-finish equipment including syringe assembly, serialization lines, and cartoners. Strong understanding of GAMP 5 and validation lifecycle documentation. Hands-on exposure to Greenfield projects. Excellent communication and documentation skills. Experience managing deviations, CAPAs, and change controls.