CPL, in conjunction with our client Pfizer, are currently recruiting for QA Operations Specialists to join their facility at Grange Castle, Dublin 22.
- Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), site policies/procedures, regulatory requirements and industry standards.
- Partner closely with customers and stake-holders to understand and deliver on all records within timelines and escalate when necessary.
- Participate in cross functional teams as required to provide consultative support on quality related issues. Provides support with investigations and resolution of discrepancies. Assure completeness in terms of root cause, action taken, and CAPA.
- Author, track, review for adequacy: procedures, investigations, commitments (Regulatory Agency, investigation, audit, etc), change controls, forms, logbooks, protocols and reports etc.
- Support the review and approval of applicable APQRs
- Continuous monitoring of systems for compliance, robustness and driving zero defects, participating/supporting cross-functional teams as required.
- Contribute with site trending of investigations in line with site procedures and reporting these trends to Site Quality Review Team.
- Participate in the internal audit program as required.
- Relevant Third Level Qualification or Equivalent
- Previous relevant Quality experience as detailed above in the job responsibilities section
This is an initial 11-month contract.