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QA Batch Release Officer
7 days ago
We are currently looking for a QA Batch Release Officer to join a leading Biopharmaceutical business based in the Hertfordshire area. As the QA Batch Release Officer you will be responsible for reviewing and supporting manufacturing batch records in preparation for QP disposition, as well as the following:
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QA Batch Release Officer will be varied however the key duties and responsibilities are as follows:
1.Gain an understanding and knowledge of the process flow applicable to batch documentation reviewed.
2.Review and understand deviations and changes related to batch review and be able to assess them on behalf of the QP.
3.Complete transactions and updates in systems that support batch review, such as LIMS and Trackwise.
4.Complete batch review monitoring as required with associated logs and local spreadsheets.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the QA Batch Release Officer we are looking to identify the following on your profile and past history:
1. Relevant degree within a scientific discipline would be beneficial.
2. Proven industry experience with Batch Record documentation.
3. A working knowledge and practical experience of working within a bio pharmaceutical manufacturing environment.
Key Words: Batch Records | GMP | Biopharmaceutical | Batch documentation | Batch review | QA | Quality Assurance | QA Officer | Clean Room | Manufacturing
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