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External Site Quality Leader

  • Salary: Up to £1 per annum
  • Job type: Permanent
  • Location: Ireland
  • Sector: Science
  • Date posted: 19/09/2018
  • Job reference: BBBH87876

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External Site Quality Leader

Has responsibility for Quality Assurance and control functions to include direct support, coordination and oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight. These components may include review of batch documentation and deviation investigations.

Responsibility for quality oversight of External manufacture sterile pharmaceutical products for my client, ensuring that the goods were produced in conformance to all applicable policies and procedures and compliance with all governing regulations.

  • Monitors efforts to improve external quality and reliability through ongoing oversight and formal communication programs and forums.
  • Provides support to validate new product introductions
  • Will provide onsite quality support for all Regulatory Authority Inspections
  • Conducts quality due diligence assessments for pre-approval considerations of new External manufacturing
  • Coordinates significant investigations including Fact Findings and product recalls as needed.
  • Assures the development and maintenance of a Quality Agreement. Provides input into the development of contractual agreements with the External Partners
  • Executes a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the External Partners
  • Directs the EQA EU cGMP program including maintaining permanent inspection readiness at sterile External Partners


  • Degree or 3rd level qualification (Chemistry, Microbiology, Production, Mechanical, Minimum of 10 Years of Experience in the Pharmaceutical industry, including Aseptic Processing and Quality Operations experience.
  • People management experience required.
  • Experience in Contract Manufacturing Oversight (CMOs, Labs, etc.) required.
  • Quality Agreement negotiation and implementation skills are required.
  • Qualified Person (desirable but not a mandatory)

For more information on this and other senior level positions please feel free to contact Kathyn on 016455250

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