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.
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.
- 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.
- 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 firstname.lastname@example.org