Quality QP Manager
- Job type Permanent
- Location Dublin, Republic of Ireland
- Sector Pharma & Biotech
Global speciality pharmaceutical company is seeking a Quality/QP manager. This managerial position provides for leadership for onsite Quality aspects at the Manufacturing Facility, Dublin.
This facility is transitioning from project to sustained phase in 2018 with a number of Regulatory Inspections pending. The role provides Quality Management for the manufacturing process at the facility, a site proposed to manufacture API material. The associated drug product is approved in the U.S. for certain autoimmune and inflammatory conditions.
The role includes complete signature authority, with responsibility for escalating high risk issues to management. The position also acts as a consultant to management regarding compliance issues and may lead very large projects that could cross site or divisional lines. The incumbent will coordinate compliance activities / projects with key groups. The role will have Quality Assurance, Quality Control, QA Validation and Cleaning Validation teams reporting into it. Day to day:
- Day to day leadership for Quality aspects of the facility including QC testing, QMS implementation and oversight.
- Member of the College Park plant management team for College Park manufacturing facility who decide and implement strategy and direction.
- Certification and Release of API lot(s) in accordance with EU & US cGMP requirements.
- Eligible to perform the Qualified Person (Q.P.) role in accordance the legislative requirements within Article 51 of Directive 2001/83/EC and Article 55 of Directive 2001/82/EC3.
- Oversight and Governance of all Product/Technical Transfer(s) with 3rd parties from a Quality perspective.
- Minimum BSc
- Qualified Person status (or 2nd year of training in process) required
- Minimum 10 years' experience in a QA or equivalent role
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