selection and qualification). Act as a quality assurance consultant in the development and implementation of quality systems... Quality prospective. Support transfer projects and Supplier localization projects. Support IQ, OQ, PQ and PPAP processes...
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...
QA Systems & Compliance Associate Location: Totowa, New Jersey (Onsite) Department: Quality Assurance – QA Systems... and inspection readiness. Quality Engineering & Validation Support validation and qualification activities, including IQ/OQ/PQ...
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...