, Risk Assessments, IQ/OQ/PQ, RTM, Summary Reports). Ensure risk-based validation approaches aligned with GAMP 5, 21 CFR...
and execution or review of validation protocols (IQ, OQ, PQ). Develop, review, and maintain work instructions, manufacturing...
- Manufacturing Engineering. Good Experience working on Process Validations (IQ, OQ, PQ) Experience developing manufacturing...
and review of DMR/DHR documentation and execution or review of validation protocols (IQ, OQ, PQ). Develop, review, and maintain...
/OQ/PQ execution o Equipment qualification documentation o Validation protocol review and approval Ensure alignment... Experience reviewing and remediating manufacturing documentation. Working knowledge of equipment qualification (IQ/OQ/PQ...
and execution or review of validation protocols (IQ, OQ, PQ). Develop, review, and maintain work instructions, manufacturing...
product, equipment, and process validations including IQ/OQ/PQ. Experience managing prototype and pilot production builds...
/PQ), and first article inspections (FAI) as part of supplier readiness. Lead structured problem-solving efforts...
development & process characterization Good experience in Process Validations - IQ, OQ, PQ Experience in test fixture design...
of validation protocols such as IQ, OQ, and PQ. Develop, review, and maintain work instructions, manufacturing procedures...