Quality Assurance Manager (Onsite once a week)
RK5141
Contract 12 months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Key Responsibilities:

• Maintenance of External Supply Quality licenses as it relates to global GMP/GDP activities (MIA, ASR, WDA)
• Ensuring the review, and where appropriate, preparation and regular update of Quality Agreements with outsourced partners.
• Owner and approver of GMP/GDP QMS documents
• Support the annual Quality Management Review meeting and co-ordination of any actions from this meeting for implementation.
• Preparation and periodic review of Bona Fides
• QA approval of deviations/non-conformances ensuring deviations are fully investigated and that remedial measures are implemented to address the root cause of failures and relevant actions are taken to prevent their re-occurrence.
• QA approval of change control proposals (third party contractors and internal) and action plans.
• Coordinate mock recall task force team to test the recall process in accordance with governing procedures and issuance of report with recommendations and corrective action plans for any deficiencies identified.
• Support OpEx programs and champion continuous improvements and initiatives

• Bachelor’s Degree in a Science Field
• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Ability to oversee multiple projects simultaneously
• Ability to travel +/- 10% of time to domestic and international sites