An industry leading clinical and commercial pharmaceuticals manufacturing group with a network of global locations is looking to hire a Senior Quality Assurance Specialist for their team in Tredegar. Following continued growth, the role has been newly introduced and will be the main QA project lead for client facing QA activities supporting the introduction of new products into the business.
The business offers a broad range of contract development and manufacturing services for clinical and commercial products. Whilst not an immediate requirement for the role, you will be offered the opportunity to develop and train to become a Qualified Person.
Your key tasks as Senior Quality Assurance Specialist:
- To be the Quality lead to operations for new and ongoing projects.
- QA interpretation of regulatory guidelines for continued compliance.
- Promote quality culture throughout the business to raise performance and eliminate waste.
- Audits and follow up actions within site business units.
- Review and approve Master Batch Records, Technical specs and Technical Agreements
- Batch record compilation and regulatory checks
- Review and interpret PQR data.
- Use judgment to make appropriate product quality decisions (with QP's) and promote quality improvements to prevent re-occurrence.
- To ensure that products proposed for release by a site QP were manufactured in accordance with license requirements, clinical trial application and cGMP
- To assist with GMP training within the department and cross site.
If you have experience in the above responsibilities and can support this with the below background, then you would be a great fit for this position:
- Significant experience in the pharmaceutical industry, with a diverse knowledge of various dosage form manufacturing
- Experience within Quality department in a pharmaceutical company.
- Experience of networking with internal and external partners to bring projects to completion.
- Detailed knowledge of cGMP
- Ideally qualified to Degree level in a science, engineering or similar field
This is a well-rounded role that will allow you to develop and hone your QA experience whilst helping to grow a leading pharmaceuticals group.
A salary of £45,000 to £50,000 is on offer for the Senior Quality Assurance Specialist with flexibility to increase on this to secure the right person.
This position is an important hire, so the intention is to begin interviewing from mid-September. Please apply as soon as possible to be considered. You can also contact James Ivall at Goodman Masson should you have any questions or want to discuss the role in more detail prior to applying.