£25.58ph via Approved UMB
The QA Batch Release Specialist will review and release batches to supply fully compliant material with delivery of customer service whilst maintaining quality and safety standards for the area of their responsibility.
- Review and verdict documents from production areas for bulk and intermediate product release while maintaining an efficient service in line with customer demands for the release of manufactured batches.
- Give advice and assistance across site on a range of GMP topics. May be expected to carry out GMP or corrective training.
- Review and approve documents as the Quality representative such as SOPs and technical reports.
- Support validation document review and understand the impacts of change control in the area.
- Play an active part in deviation management of all types of Quality SAP notifications and reduction programs by being active in the deviation coordination and investigation process. Will provide Quality approval in accordance with site deviation management procedures.
- Expected to represent QA at the Value Stream accountability and compliance meetings and to support all performance management activities with agreed timelines and metric requirements
- Plan and prioritise work of self and colleagues when directed to do so by the area Manager.
- Use GPS process tools such as GEMBA/Process Confirmation/5S techniques to review and identify weaknesses and recommend improvements within Quality and Orals Manufacturing and Packaging processes.
- Understand the GSK QMS and its application to Worthing processes.
- Understanding of the regulatory requirements for the area they support.
- Adhere to the requirements of the GSK Values and Expectations.
The role will be required to perform calculations, review, analyse and make complex decisions using data provided.
- A-levels or equivalent in Science and Mathematics - Chemistry/Biology/Mathematics or equivalent.
- Working knowledge of cGMP, across aligned manufacturing and/or packaging areas
- The ability to work in and lead cross functional teams.
- Flexible working as determined by the Business needs.
- Good organisation and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy.
- Excellent communications and interpersonal skills at all levels both written and verbal.
- Understanding and ability to demonstrate use of continuous improvement techniques.
- Knowledge of deviation management and regulatory requirements.
- Knowledge and understanding of laboratory testing including out of specification investigations.
- Adheres to all applicable GSK personnel policies.
If you feel you would be suitable for the role of QA Specialist, please apply with your most up to date CV