PE Global are currently recruiting for a QA Specialist for our client site in Tipperary:
11 month initial contract
Job Purpose
The Specialist is a member of a team within Quality and is involved in supporting the GMP Quality Assurance activities at the Ballydine site.
Key Result Areas and Primary Activities
1. Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
2. Perform and review complaints and deviation investigations, change controls and CAPA’s.
3. Create and maintain assigned SOPs.
4. Compile data for reports and presentations, provide data interpretation and draw conclusions.
5. Complete audits to ensure compliance to SOPs, GMPs and applicable regulations.
6. Support product recalls and stock recoveries as appropriate.
7. Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
8. Identify compliance gaps and make recommendations for continuous improvement.
9. Assist in the induction process for new starters and training of other staff.
10. Generally, follow standard procedures and consult with manager/supervisor on exceptions.
11. Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements.
12. Keep abreast of cGMP requirements as described in applicable worldwide regulations.
13. Represent the department on cross-functional teams.
14. Additional activities as assigned by the manager/supervisor.
Skills Required
1. The Specialist is required to possess a degree in a Science or Engineering discipline plus some industrial experience.
2. Alternatively, they must possess considerable industrial experience.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on 021- 4297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net.
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