processes, equipment, and systems, including commissioning and qualification activities and the development/execution of IQ, OQ... from concept through implementation and start-up. Interface regularly with quality control, quality assurance, production...
Assessments, Traceability Matrices, and Validation Summary Reports. Execute and oversee IQ, OQ, and PQ activities. Ensure..., migrations, and decommissioning projects. Coordinate validation activities with IT, Quality Assurance, Engineering...
, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Pharmacokinetics and Drug Metabolism, Clinical... functions, such as Drug Substance Technologies, Attribute Sciences, Quality Assurance, Regulatory Affairs, Supply Chain...
and operate Vision System inspection machines. Lead and participate in validation activities (IQ, OQ, PQ) for equipment and new....Provide leadership and guidance on quality assurance practices during the product lifecycle.Analyze quality data, identify...
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities. Ensure calibration... Control, Instrumentation, Engineering, Automation, Quality Assurance, and system owners to plan and execute validation...
Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Author..., Quality Assurance, Manufacturing, Automation, and Regulatory teams. Mentor junior validation engineers and specialists...
equipment, utilities, facilities, and systems. Develop and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ documentation..., Automation, Manufacturing, Quality Assurance, Facilities, and external vendors. Provide technical leadership and mentoring...
and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities... maintenance of validated state. Author and execute IQ/OQ/PQ protocols, and reports for equipment and computerized systems in QC...
Assessments, Traceability Matrices, and Validation Summary Reports. Execute and oversee IQ, OQ, and PQ activities. Ensure..., migrations, and decommissioning projects. Coordinate validation activities with IT, Quality Assurance, Engineering...
with Quality Assurance and Engineering. Supplier Performance & Risk Management Monitors supplier performance, identifies risks... and mitigation plans in collaboration with Quality Assurance and Materials teams. Collaborates with suppliers and internal...