Qualification (PQ). Commission/Re-commission EO Sterilization Chambers, Sterilization adoptions, and Radiation Dose Audits (Gamma...
and validation strategies (IQ/OQ/PQ) in accordance with regulatory and internal standards. Execute activities required for the...). Experience in validation (IQ/OQ/PQ), process mapping, and quality systems is strongly preferred. Communication Skills: Clear...
protocols (IQ/OQ/PQ). Knowledge of laboratory-specific engineering systems including fume hoods, biosafety cabinets...
/QC) and methodologies for defect management is expected. Knowledge for formal validation protocols (e.g. GxP, IQ/OQ/PQ...
investigations, design of experiments, process capability studies, and process validations (IQ, OQ, and PQ). Author or revise...
, product failure and root cause analysis 3+ years of experience with process and product/system validations (IQ/OQ/PQ...
(IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP) 5+ years of experience...
implantation. Drive validation and qualification (IQ/OQ/PQ) protocols for new product, equipment, tooling and processes...
implantation. Drive validation and qualification (IQ/OQ/PQ) protocols for new product, equipment, tooling and processes...
) Extensive experience with dFMEA, Control Plans, and Validations (IQ/OQ/PQ) Metrology experience Must have experience...