) and Performance Qualification (PQ), test method validation protocols (TMV) and analytical test methods. Provide guidance/direction...
with process, controls, maintenance, and quality teams to resolve chronic equipment challenges. Support FAT/SAT, IQ/OQ/PQ...
, 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...