A leading sterile pharmaceuticals manufacturing business is recruiting for a Quality Assurance Manager & Qualified Person to take ownership of quality processes and systems across the business for batch release operations. This position is based in Dublin.
The business is a leader in its field and partners with global biotech organisations. They are an innovative and highly regarded organisation with multiple sites in the UK and multinational operations. They are busy and growing fast and now need additional QA and QP support.
The Quality Assurance Manager will work with group leaders across Manufacturing, Quality Control and Engineering to provide technical expertise across quality related processes and will also support Quality Assurance functions across the wider group. The Qualified Person function will support the batch release of sterile products on a regular basis.
As Quality Assurance Manager, you will:
- Quality Systems management across all operations - Approval, change cont., quality improvement and compliance.
- QP release sterile product manufactured on-site
- Ensure EU cGMP for all manufacturing operations.
- Promote total quality culture throughout site. Link with manufacturing/QC to improve performance and compliance
- Hosting of external audits and inspections at the manufacturing site and managing responses
- Lead compliance projects and ensure the business meets regulatory commitments
- Co-author, review and authorise the content of APR reports
- Provide technical support for R & D, clinical research and regulatory
If you have the following experience, you would be a great fit:
- Eligible for nomination as a Qualified Person on the site Manufacturers Licence. Both current Ireland and EU QP's are being considered.
- Strong experience in the manufacture of pharmaceutical products, preferably sterile products. Training in steriles will be provided to QP's with a non-sterile background.
- Qualifications to degree level (or equivalent) in chemistry, microbiology or pharmacy or comparable scientific discipline
- Excellent analytical problem-solving abilities and able to lead by example
The salary on offer is €80,000 - €90,000 with the potential to go higher for a great candidate.
The perks and benefits included in the package are excellent and include bonus scheme and big company benefits.
Interviews are already under way so, if of interest, please apply as soon as possible to be considered for interview or contact James Ivall at Goodman Masson for more information.
Look forward to hearing from you.