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