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Contact Info
Paula O'Reilly
Life Science

+353 1 507 9265
[email protected]
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Details

QC Raw Materials and Compendial Associate Director


Reference:POR/075372 Location: Louth
Qualification:MastersExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

AQC Raw Materials and Compendial Associate Director is required to join a Global Biologics organisation on a permanent basis. This is a permanent role offering you the opportunity to work on a state of the art facility. As QC Raw Materials and Compendial Associate Director you will be responsible for ensuring the highest standards of professional regulatory adherence excellence and quality within the business, with overall responsibility for the management of QC instruments/equipment and analytical test methods for raw materials testing, managing raw materials specifications and raw materials release, sampling of raw materials for QC testing and managing raw materials regulatory retain samples, leading product compendial testing, and other project support functions. Working closely with senior leaders in all areas of the business, this position will play an integral role in the development of the local QC strategy/business planning, aligned closely with the global QC function.

The Role

  • From a QC functional capacity support the design, construction, and commissioning of the new facility for the production of drug substance.
  • Develop/build a world-class Biologics QC Raw Materials and Compendial testing team, including planning, recruiting/hiring, coaching/mentoring, and training for approximately 8-15 total headcount.
  • Responsible for raw materials and compendial routine testing, method verification, and method transfer.
  • Management of raw materials and compendial testing QC instruments and equipment
  • Raw materials sample management, including sampling, sample log-in and disposition, as well as routine inventory checks of regulatory retention samples.
  • Author technical documents, including relevant SOPs, testing protocols and reports, raw materials specifications, and raw materials expiries.
The Person
  • University degree in related science/quality discipline required.
  • Ph.D. with 5+ years of experience, or Masters with 7+ years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related field, desired.
  • 15+ years’ experience working within Quality Control/GMP environment with a well-rounded exposure to all areas in this field and significant experience with raw materials and compendial testing.
  • Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project Management/supervision of personnel with particular attention to schedules and shifting priorities.
  • Previous experience with regulatory inspections and internal/customer audits is strongly preferred.



For further details please contact; Paula O’Reilly on 00 353 (0)87 7094141 or send CV in confidence to [email protected]