Overview
On Site
Full Time
Skills
IQ
OQ
PQ
GMP
Startups
Collaboration
Quality Assurance
Manufacturing
Assembly
GAMP
Communication
Documentation
Management
Job Details
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.
- 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.
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