, and Test Method Validation (IQ/OQ/PQ/TMV), manufacturing documentation, process risk mgmt. & failure mode and effect analysis...;Design & manufacturing transfer of pilot line, including IQ/OQ/PQ/TMV, Process Risk Mgmt. & FMEA, process and production...
validations with a focus on process characterization Operational Qualification and Performance Qualification (OQ/PQ) per ISO11607... validations PV & OQ/PQ per ISO11607-2;and Packaging deliverables for regulatory submission and sterilization optimization...
include: User Requirement Specifications Commissioning IQ, OQ, PQ Calibration Standard Operating Procedures...
implantation. Drive validation and qualification (IQ/OQ/PQ) protocols for new product, equipment, tooling and processes...
validation, IQ, OQ, and PQ road map requirements. Proven interpersonal and communication skills, with the ability to work...
timelines, costs, capital, expense, risk and recommendations Responsible for validations, IQ/OQ/PQ, product production...
Responsibilities: Develop and execute clean room validation protocols (IQ, OQ, PQ) to ensure compliance with industry...
necessary by the business. Work closely with CPC QA department to plan and execute part validations using IQ, OQ, PQ methods...
Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities and utilities. Preferred Experience...
procedures (SOP). Participate in IQ/OQ/PQ for equipment to ensure ability to train team members on proper use and maintenance...