An industry leading pharmaceuticals group with a network of global locations is looking to hire a Qualified Person for their site based in Bridgend, South Wales. The role is responsible for the batch release of key product lines that represent a large commercial value to the group.
As Qualified Person you will take ownership of all quality aspects across production and head the release of a range of flagship sterile and biologics product lines. This is a commercially focused quality position that will network with senior stakeholders in leading pharma's and partner with senior leadership internally to help drive the continued development of the group.
The business work across a wide range of dosage forms from non-sterile to biologics, IMP and Commercial, so you will gain experience in all product forms. The QA Director is committed to providing the new QP exposure to all areas of the business so that you can develop your skillset to become a subject matter expert for the group.
Key Responsibilities as Qualified Person:
- QP release and operational oversight of the process for all production operations released to the EU and globally.
- Support quality audits to ensure that external partner MA holder manufacturing sites are operating in compliance with EU GMP.
- Support key aspects of the Quality Management System and help drive operational improvements
- Championing quality as a key business partner for commercial operations.
- Where required, deputise for the Lead Qualified Person.
You will have the following experience:
- Experience working as a QP in the certification of sterile products. UK or eligible EU QP's.
- Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with EU directives 2001/83/EC and 2001/20/EC.
As the business is a fast-paced contract pharmaceuticals group you will quickly be able to develop your commercial acumen with access to all areas of the organisation. The company works with the world's leading pharma's and biotech's so the role will provide regular contact with a global customer base.
A salary of £75,000 - £90,000 is on offer depending on prior release experience to attract a great candidate and can go higher. There is also a good benefits package on offer with full flexibility on working hours.
This Qualified Person vacancy is a key hire and the intention is to begin interviewing through January so please apply soon 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.