One of the world's leading biopharmaceutical manufacturers is searching for a Quality Manager and Qualified Person in Dublin.
The business, who manufacture a wide range of sterile and biologics products, have grown rapidly in recent years and are now widely regarded as the top high-growth pharmaceuticals group to work for. They have a reputation for excellence and provide a platform for growth to talented individuals looking to hone and develop their skills at the leading edge of the industry.
This Qualified Person position will lead batch release operations for the manufacture of biologics products and provide QMS support to key partner organisations as subject matter expert. As Quality Manager you would also lead projects ranging from site strategy/improvements to global quality harmonisation.
- Leading the review process for batch documentation, data and technical reports
- QP release of batches in alignment with Quality Management Systems and GMP regulations
- Managing, designing and implementing quality management systems for batch release operations
- Manage continuous improvement initiatives in the batch release team and support continuous improvement initiatives in the group
- Meeting and continuously improving quality metrics across your group
- Facilitating, approving and providing inputs into deviation investigations, change controls, CAPA, investigations and non-conformance reviews as required
- Managing batch disposition processes
Key experience required:
- Strong technical/Quality background with specific experience in sterile/small molecule manufacture and batch release. Ideally exposure to biologics products.
- Must be an eligible Qualified Person with experience as a QP on the license (you do not need to have a lot of experience on the license but must have a good hands-on grounding e.g. 6-12 months QP experience minimum)
- Ideally manufacturing site experience. Candidates without manufacturing site experience will need to evidence a good understanding of the process.
- Thorough knowledge of GMPs and Quality Systems
- Experience conducting audits and/or involvement in preparation for HPRA inspections.
A salary of €85,000 - €95,000 is on offer dependent on the level of prior experience with an excellent benefits package.
The Qualified Person is an important hire for the group and so interviews will be held within the next few weeks ideally. If you are considering a move and this looks like it could right next step, please apply as soon as possible to be considered for interview.
You can also contact James Ivall at Goodman Masson to discuss further. Hope to hear from you soon.