in a technical or engineering environment Exposure to GxP environments or validation protocols (IQ/OQ/PQ, FAT/SAT) in pharmaceutical...
, Validation Plans, IQ/OQ/PQ, Validation Reports, Traceability Matrices, Automated Testing Artifacts) to ensure FDA-regulated... validation lifecycle documentation (e.g., URS, risk assessments, IQ/OQ/PQ, traceability matrices). Experience supporting...
, and facility changes, including development, standardization, and approval of IQ/OQ/PQ protocols and final reports. Define..., cleaning, equipment, and utility validation (High proficiency) IQ/OQ/PQ protocol development and execution (High proficiency...
Supplier pFMEA, IQ/OQ/PQ, inspection reports, Gage R&R, and process capability analysis Drive cost reduction, capacity...
knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PVs, etc. Advanced verbal and written...
on process validation, risk management, and change control. Top Skills (Must Have) Process Validation (IQ, OQ, PQ) Validation... lifecycle (process characterization → PQ) Test method validation & documentation PFMEA, Control Plans, risk documentation FAI...
supporting equipment qualification (IQ/OQ/PQ). Experience with aseptic processing is a plus. Experience with CDMOs and external...
environment. The role involves developing and executing IQ/OQ/PQ protocols, supporting process validation and technology transfer... protocols (IQ/OQ/PQ) for new and modified equipment, utilities, and facilities. Author, review, and approve qualification...
validation reports (IQ/OQ/PQ). Represent the organization to customers on quality issues, handle and resolve customer...
evaluations Perform process validation activities including IQ, OQ, PQ, and test method validations Conduct production floor...