Bury St Edmunds
£30000 per annum
+44 (0)151 666 8968
about 1 month ago
Norfolk, Kings Lynn, Bury St Edmunds, Ipswich, East Anglia
A multinational healthcare company is looking to appoint a QA Officer to their compounding unit on a permanent basis
The Quality Assurance Officer will work within the Compounding Unit checking the product to allow for its release. The role will be responsible for the release of batch, production complaints, deviations, change controls, updating emails and review of SOPS. The role is predominantly based with the production area with only around 25% of the time based in the office so being hands on is especially important. Products manufactured outside of QA hours will be stored in the cold room ready for release by the QA department. This is a busy role with approximately 100 plus batches expected to be made each day.
- Support delivery of product release targets
- Lead and support the execution of timely deviations and investigations
- Support the preparation & development of Annual Product reviews
- Support validation programs and change control implementation as required
- Ensure that the facility is always ready for a MHRA, corporate, an internal or 3rd party audit and ensure that audit findings are fully investigated and actions are managed in a timely manner to address the issue.
- Regularly communicate with all site staff quality issues and promote the Quality System as a business process for improvement of customer satisfaction and regulatory compliance
- Monitor all Quality System processes to identify improvement opportunities;
- Ensuring product complaints are adequately investigated and appropriate corrective and/or preventative actions are implemented
- Providing QA oversight to product and process changes and validation and Maintain a local change control process to ensure all changes are fully documented;
- At least 2 years specific QA experience in addition to any other industry experience
- A Pharmaceutical GMP background is essential and non-negotiable
- Qualified to a minimum of a BTech in Science or above.
- Aseptic or clean room experience would be ideal
Scantec Personnel Limited is acting as an employment business and an employment agency. For contract or interim roles (and unless otherwise stated), all pay rates stated are on a Limited Company basis.
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