Quality Assurance Manager

Quality Assurance Manager (Onsite once a week)
Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now.
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 that is one of the best at what they do.

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• 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. xcfaprz
  
• Support OpEx programs and champion continuous improvements and initiatives
  

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• 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
  

If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.