Strong understanding of FDA, EMA, MHRA, and other global regulatory requirements (e.g., 21 CFR Part 11, Annex 11, GAMP 5).
Proficiency in managing the full validation lifecycle : URS, Risk Assessment, IQ / OQ / PQ, Traceability Matrix, and Validation Summary Reports.
Job Details
We are seeking a Validation Lead with strong regulatory knowledge and validation lifecycle management experience.
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Qa Lead • Boston, MA, United States