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...
as a subject matter expert. Support equipment lifecycle activities (URS, FAT/SAT, commissioning, IQ/OQ/PQ). Help to maintain... and improve current sterility assurance programs, including aseptic process simulations (APS), container closure integrity testing...
Assurance Lead Computer System Validation (CSV) efforts, including writing and executing IQ/OQ/PQ protocols. Author and manage...
to collaborate cross-functionally with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and Quality Assurance. Key... and paper-based DHR systems Background in IQ/OQ/PQ validation activities Contract manufacturing environment experience...
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...
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...
) Functional Specifications (FS) Risk Assessments IQ/OQ/PQ Protocols Validation Reports Perform system impact assessments... and communication skills. Preferred Qualifications: Experience with CSA (Computer Software Assurance) methodologies. Knowledge...
will have strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, risk-based validation, and Computer Software Assurance (CSA... Assessments, test protocols, and validation reports. Execute and document IQ/OQ/PQ, UAT, regression, and risk-based testing...
according to medical device regulations. Validation experience including FAT, SAT, IQ-OQ-PQ, process characterization..., producing detailed reports. Knowledge of Quality Assurance and Quality Control systems, ideally from medical device...