Science Solutions - QC Compliance Specialist - Pharmaceuticals - Manchester - c£30k
Excellent opportunity with a Global Pharmaceutical Organisation
Ideally we are looking for 5 years in Pharmaceutical finished product QC for Solid Dose (Raw Materials, Stability Analysis) with experience of OOS/OOT & Annual Product Quality Reviews
- To assist with investigation of laboratory incidents, Out Of Specification (OOS) / Out Of Trend (OOT) in order to ensure compliance with the relevant procedures and guidance.
- To coordinate the QC input into Annual Product Quality Reviews (APQRs).
- Write Quality Technical Agreements (QTAs) related to contract laboratory services.
- To review and approve stability protocols prior to the introduction of the stability study as well as stability reports as approval for completion of the stability study.
- To review and approve Quality Control Records and Test Procedures.
- To review existing SOPs covering Quality Control procedures on an as and when basis.
- To perform internal audits of the QC laboratories and ancillary areas.
- To liaise with clients on routine QA matters, and participate in client audits/visits.
- To provide QA support for the specification, introduction and validation of new process equipment and or procedures.
- To lead GMP training sessions.
- Ensure all laboratory equipment and systems are adequately controlled, calibrated and qualified.
- To review supplied analytical methods and give constructive comments to aid in their introduction and improvement.
- Assist from a QA perspective the transfer of QC Analytical Methods for finished products and raw materials.
- The job holder must be educated to degree level in a science-based subject or demonstrable equivalent experience, with a minimum of 5 years' experience in the pharmaceutical industry, to include manufacturing/QA/QC.
- Presentation skills, and the ability to train personnel in quality matters are required
- The job holder should have good report writing, statistical evaluation and effective meeting skills.
- A thorough knowledge of the principles of equipment/ process/ analytical/ cleaning validation is required. The job holder requires a thorough knowledge of QC (chemical and microbiological).
- The job holder requires good computer skills, and must be able to produce structured technically detailed documents using Microsoft Word, Excel etc.
Please apply now to be reviewed immediately
- QUALITY REVIEW
- OUT OF SPEC
- OUT OF TREND
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