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Vacancy Details


Qualified Person / Quality Manager - Mayo

Contract Type: Permanent
Location: Mayo
Date: 9/11/2018
Job Reference: 98857

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

Quality Manager/ QP
Our client, a pharmaceutical company in Mayo is currently looking to recruit a Quality Manager for their site.

Job Responsibilities:
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 the 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

  • Requires BSc in scientific discipline with minimum 5 years of relevant work experience in pharmaceutical or related industry.
  • Education requirements for Qualified Person eligibility
  • Experience in aseptic manufacturing and sterilisation processes (example: Filter Sterilisation) is desireable.
  • Proficient in MS Office (Word, Excel, Outlook, and PowerPoint)
  • Strong Technical writing ability
  • Contentious and reliable worker
  • Excellent communication and presentation skills both verbal and written, with the ability to engage with a diverse range of individuals across all levels of the organisation.
  • Ability to develop a good working relationships across functions
  • Ability to understand and articulate quality requirements in a clear, consistent and coherent manner

For further information on this Quality Manager role in Mayo please contact Bimi on 086 8395531 /

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