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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Quality Operations Manager, Drug Product


Reference:SCADQS-402802 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Quality Operations Manager, Drug Product
Our client, a global pharmaceutical organisation based in Dublin are currently recruiting for Quality Operations Manager, Drug Product, to join their team on a permanent basis.


Responsibilities:

  • Support the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer
  • Actively support the Product Review Committee (PRC) processes for major investigations involving Third Party products
  • Provide quality/compliance support to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MT teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs etc
  • Provide the requisite quality support to global functional groups such as Global Regulatory/CMC and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions etc
  • Coordinate quality metrics programs in relation to Third Party performance
  • Provide support to Quality Operations Management Team in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties
  • Assist in the preparation of Quality Agreements with the Third Party Manufacturers
  • Review the Annual Product Reviews submitted by the Third Party Manufacturers
  • Support the global external auditing program by participation in audits of Third Parties as requested
  • Provide support to specified quality and technical projects as they arise
Requirements
  • A BSc in a scientific discipline such as Chemistry or Microbiology
  • Minimum 5 years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency
  • Experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
  • Ideally will have experience in interacting with Health Authorities and supporting Health Authority inspections
  • Direct experience in interfacing with external manufacturers
  • In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
  • Ability to develop cross-functional and external working relationships
  • Strong communication and presentation skills across
  • Proven analytical and problem solving skills