validation documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices...
). Prepare detailed validation protocols for IQ, OQ, PQ, execution and write the validation reports in close cooperation... Engineering or equivalent. Able to write validation (IQ, OQ and PQ) documents for new products, processes, and equipment...
equipment issues, process validation documentation including PFMEA, IQ, TMV, OQ/PQ, statistical analysis of process data...
Office including MS Project and PowerPoint experience is strongly preferred. Experience with IQ/OQ/PQ protocols...
and completeness. Partner with Manufacturing and Process Engineering on validation strategies (IQ/OQ/PQ alignment with design intent...
/PQ) Validation Summary Reports and Periodic System Reviews Perform requalification of existing computer systems...
equipment validation including IQ/PQ/OQ in regulated environment Experience supporting in a GMP environment Excellent written...
(URS), IQ/OQ/PQ, etc. Associates Degree (± 13 years) with Related with 10-15 years relevant experience. Bachelors...
, integrations, etc. Execute and document test cases (IQ/OQ/PQ/UAT) in accordance with IT Change Control and validation procedures...
communication skills. MS Office including MS Project and PowerPoint experience is strongly preferred. Experience with IQ/OQ/PQ...