CQV Engineer
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We are looking for a CQV Engineer / Validation Specialist to support qualification and validation activities for equipment, systems, and related documentation within a regulated pharmaceutical environment. The role will involve preparing, reviewing, executing, and closing out key validation documents in line with project requirements and GDP standards.
* Prepare high-level documents including SRA; draft for comments, incorporate feedback, and obtain approval.
* Prepare Design Qualification (DQ) draft protocols for comments, incorporate feedback, and obtain pre-execution approval. Execute approved DQ protocols, identify non-conformances to User Requirements Specifications, and prepare DQ summary reports.
* Draft Requirements Traceability Matrix (RTM) for comments, incorporate feedback, and obtain approval.
* Review and comment on pre-execution vendor commissioning protocols. Witness protocol execution, ensuring testing is completed and test results are recorded in accordance with GDP.
* Draft Installation / Operational / Performance Qualification (IOQ) protocols, issue for comments, and obtain pre-execution approval. Conduct IOQ protocol execution, manage and close out deviations, and prepare summary reports upon completion of OQ, or PQ where the equipment/system is subject to PQ.
* Draft PQ protocols, issue for comments, and obtain pre-execution approval.
* Execute PQ protocols, manage and close out deviations, and prepare summary reports upon completion of PQ.
CMC is an equal opportunity employer. We welcome applications from individuals of all ages and backgrounds and assess candidates solely on merit, skills, and potential. No terminology in this advert is intended to discriminate in any way.
We welcome applications/enquiries from individuals of all backgrounds and are committed to providing equal access to employment opportunities across all regions in which we operate.