Validation engineer
Kasmo Global
CQV Engineer
Design Documentation: URS, FRS, DS, and other engineering specifications
Validation Processes: IQ, OQ, PQ, Process Validation (PV), Computer Systems Validation (CSV), Master Validation Plan (MVP)
Quality Systems: Change Control, Non-Conformances, Requalification protocols (IQ/OQ/PQ) in compliance with GMP, FDA, and other regulatory requirements
Regulatory Compliance: Understanding of cGxP principles, ISO 13485, ISO 14971, and 21 CFR 820
CQV Leadership: Leading CQV efforts for new and existing systems, troubleshooting issues, collaborating with cross-functional teams, preparing detailed validation documentation, and ensuring regulatory compliance
Vacancy posted 4 days ago
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