QA Specialist - 11 Month Contract with potential extension- Hybrid
The Contractor is a member of a team within Global Development Quality (GDQ) and is involved in supporting the GMP Quality Assurance activities for the GDQ IMP Licence at the Ballydine site.
Role Functions (Functions include, but are not limited to, the following)
- Completes audits of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to SOPs, GMPs and applicable regulations.
- 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.
- 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.
- Support product recalls and stock recoveries as appropriate.
- Identify compliance gaps and make recommendations for continuous improvement.
- Creates and maintains assigned SOPs.
- Perform and review complaints and deviation investigations, change controls and CAPA's.
- May assist in the induction process for new starters.
- Generally follows standard procedures and consults with manager/supervisor on exceptions.
- Compiles data for reports and presentations - May interpret data and draw conclusions.
- Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
- Keep abreast of cGMP requirements as described in applicable worldwide regulations.
- Additional activities may be assigned by the manager/supervisor.
Experience, Knowledge & Skills
- The contractor is required to possess a degree in an Engineering or Science discipline.
- Alternatively, they must possess significant industrial experience.
Qualifications & Education
- The contractor is required to possess a degree in an Engineering or Science discipline.
- Alternatively, they must possess significant industrial experience.
