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Ref: PECOS04593P

QA Specialist

  • Nationwide / Dublin South / Dublin
  • Negotiable
  • Contract
  • Updated 17/02/2017
  • Catherine O'Sullivan
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QA Specialist- Projects


PE Global is currently recruiting for QA Specialist for one of our clients in Dublin. Please call Catherine on 0214297900 for more information.


Purpose of the role:


Providing Quality oversight for Tech Transfer Projects to ensure compliance with regulatory and cGMP requirements during the design, qualification and operational readiness phases for a number of site critical projects. This role is required to partner with relevant departments to ensure that key quality systems are operated and maintained in a compliant manner.


Responsibilities of the role:

  • To provide consultative support on quality related issues to project teams.
  • Participate in cross-functional teams as required
  • Ensuring all production steps have been performed and verified, that all limits and specifications have been met
  • QA support for qualification activities - review and approve equipment/utility qualification documentation from design to post execution
  • Review / approval of technology documentation
  • Review/approval of production instructional documentation (SOPs and batch records) to ensure they are up to date, compliant, and support efficient production
  • Carryout cGMP compliance area walk-throughs of Manufacturing Operations as required
  • Participate in the internal audit programme as required
  • Maintain tracking system for project document review status
  • Review event/investigation reporting including support of Manufacturing Operation teams with investigations and resolution of discrepancies
  • Co-ordinate and review change controls as required
  • Perform completion of batch disposition packs within required timelines /Work with site QPs to ensure timely issue resolution to final disposition
  • Review of regulatory documentation
  • Assist in the creation and maintenance of up to date QA policies, SOP’s and reports
  • Assist in the development of training curricula and records for the QA Operations Group



  • B.Sc. degree in biology, chemistry or equivalent
  • 4 years experience in a pharmaceutical manufacturing environment, preferably in a quality assurance or quality control role
  •  1 year experience in a lead role desirable


If you are interested in this position, please forward your CV to or call 0214297900

PE Global

PE Global


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