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Contact Info
Libby O'Donoghue
Life Science

+353 1 507 9254
[email protected]
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Quality Operations Senior Specialist (LOA008170)

Reference:A008170 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Temporary ContractSalary: Not Disclosed
May be suitable for: QA Specialist

The Role
This Pharmaceutical company is looking to recruit aQuality Operations Senior Specialist, Drug Product, EMEA and Asia Pacificon a 12 month fixed-term contract (maternity cover)to provide quality and compliance oversight support to the Quality Operations management team within External Manufacturing.

Key Duties and Responsibilities:

  • Support the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships.
  • Actively support the Fact Finding (FF) and 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 and Alliance Partners.
  • 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.

Qualifications,Knowledge and Skills Required:

  • 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 all levels both internal and external.
  • Proven analytical and problem solving skills.
  • 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 firsthand 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

Why you should apply

  • You will help patients in their fight against serious diseases
  • You willbe part ofa company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
  • You’ll get a competitive salary and a great benefits package