Biology, Cross-Functional, ISO (International Organization for Standardization), Manufacturing, Medical Equipment, Offshoring, Process Validation, Project Execution, Project/Program Coordination, Regulations, Time Management, Validation Documentation, Validation Plan, Writing Skills
Job Description:
- Prior experience mandatory in medical devices domain,
- Plan, lead & co-ordinate project execution & validation activities in alignment with ISO 13485, ISO 14971.
- Support validation planning & execution (IQ, OQ, PQ) for equipment, process & product transfers.
- Author & review validation documentation,
- Collaborate with cross functional teams,
- Coordinate with customer, manufacturing plant & offshore team to ensure project continuity and on time delivery.
- contributed as PM/PL will be an added advantage.
Skills: Life Sciences - Regulatory Affairs
Experience Required: 6-8.
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Katalyst Healthcares & Life Sciences