QA Specialist, Pfizer, Dublin 22

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Job Description

CPL, in conjunction with our client Pfizer, require a number of QA Specialists to join the project and NPI team at Grange Castle, Dublin 22.


Role background:

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. 

Job Responsibilities: 

  • To provide consultative support on quality related issues to project teams. 
  • 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. 
  • Assist in the creation and maintenance of up to date QA policies, SOP’s and reports. 

Education/Experience 

  • B.Sc. degree in biology, chemistry, or other related technical degree. 
  • Min 4 years working experience in a pharmaceutical manufacturing environment, in a quality assurance role. 

This is initially a contract role. Up to 18 months.

Please email CV to cormac.obrien@cpl.ie

Apply via LinkedIn

Cormac O'Brien

Consultant cormac.obrien@cpl.ie
  • Salary:Negotiable
  • Location:West Dublin
  • Type:Contract
  • Category:Science
  • Ref.no:JO-1806-410654_30