Product Release Quality Manager/ QP

The Product Release Manager will hold responsibility for QA activities in support of  Unit Dose through the Product Release Function. The role will provide support to the QA/QP Associate Director in addition to the Business Unit Leader in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements as lay down by the FDA, EU and regional Ministries of Health as relevant.

  • Act in the capacity of a Qualified Person in accordance with Annex 16, EudraLex, Volume 4 and directive 2001/83/EC to support disposition of Allergan Pharmaceutical Products
  • Manages the batch disposition process to ensure timely release of products
  • Ensures the batch disposition process maintains compliance with site practices & regulatory requirements
  • Support the deviation/ non conformances/CAPA program
  • Support the Change Management program in the Business Unit
  • Be a SME for quality records and quality systems, ensuring consistency of records
  • Promote technical writing and quality awareness
  • Provide Quality support to site projects
  • Identify and support aseptic improvements
  • Support the Self-Inspection program
  • Inspection Management: (Coordinate site GMP inspections; Internal site preparation; pre-audit MOH requests; Response/report compilation & issuance; Post audit commitment management);
  • Quality metrics & monthly quality system & Senior Management review and Local Management Review meetings; (Meeting preparation and coordination of post meeting commitments)
  • Represent quality at daily & weekly cross functional meetings
  • Manage regulatory standard/guidance revision assessments
  • Support the site quality plan and ensure plan execution
  • Coordinate compliance initiatives

•  Support the Site Quality Risk Management Program

Your Recruitment Consultant is Sean Winstanley

Sean Winstanley
Sean joined Arcon Recruitment in early 2018 as our Specialist Technical Recruiter. Originally from the UK, now settled in Ballaghadrereen, Sean brings a wealth of recruitment experience in the IT / Technical arena. Sean has developed excellent skills account managing international, high profile clients solving their recruitment dilemmas.