QA Specialist – Pfizer

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Job Description

CPL, in conjunction with Pfizer, require QA Specialists to join their biologics plant at Grange Castle, Dublin 22.

Job Description:

Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), site policies/procedures, regulatory requirements and industry standards.

Participate in cross functional teams as required to provide consultative support on quality related issues. Provides support with investigations and resolution of discrepancies e.g. Method 1 etc. Assures completeness in terms of root cause, action taken, and CAPA.  

Further responsibilities:

  • Annual Product Record Reviews (APQRs).
  • Ensure that operational instructional documentation (SOPs and batch records) are up to date, compliant, and supports efficient production.
  • Perform completion of batch disposition packs including review of batch records and event/investigation reporting within required timelines.  This includes identification of discrepancies and ensuring all steps have been performed and verified, that all limits and specifications have been met.
  • Customer Complaints
  • Facilitate creating and maintaining the schedule for completion of Annual Stability Program.
  • Preparation of Supplier Quality Agreements in conjunction with supplier quality management teams.
  • Liaising with business and purchasing as part of the supplier sourcing and assessment process 
  • Support and participate in site self-inspections, internal audits, board of health audits and third party audits.
  • Assist in the development of training curricula and records for the QA Operations Group.

Your experience/requirement:

  • Relevant Third Level Qualification 
  • Previous relevant Quality experience as detailed above in the job responsibilities, within a QA GMP environment in a Pharma/Biotech company.

This is an initial 11-month contract with a view to an extension/permanency

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Cormac O'Brien

  • Salary:Negotiable
  • Location:West Dublin
  • Type:Contract
  • Category:Science