Quality Assurance Specialist - Pharma - Carlow, Ireland - 11-Month Contract
With worldwide demand for their life-changing oncology treatment increasing, one of our global pharmaceutical clients is looking for a Quality Assurance Specialist to join their team to support multiple capital projects onsite.
This is a fantastic opportunity to work on a state-of-the-art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US.
Role Summary:
1. Review and approval of all manufacturing batch documentation including electronic batch records, real-time reports, and master data using the site systems.
2. Review and approval of SOPs, cleaning verification/validation data, and other documents as necessary for the IPT department.
3. Drive effective writing, revising, and rolling out of accurate operational procedures, training materials, and maintenance procedures for various Quality-related systems; ensure all work is subsequently carried out in line with these.
4. Support the development and implementation of improved quality reporting measures.
5. Liaise with the Quality Specialists/QP/QA Lead to resolve queries related to the batch manufacturing process.
6. Provide effective real-time on-the-floor support for day-to-day manufacturing operations, such as area clearances, batch record reviews, and aseptic operations.
7. Provide quality input into decision-making processes on the shop floor, ensuring product quality is maintained.
8. Provide training in all aspects of Quality Management Systems and GMP.
9. Ensure all work is carried out in line with SOPs, training, or other quality systems such as change controls where applicable.
10. Facilitate compliance for the site by assisting in adherence to divisional policies, guidelines, and regulatory requirements.
Experience, Knowledge & Skills:
1. Relevant experience in a quality role, ideally within a pharmaceutical manufacturing environment.
2. Knowledge of US and European cGMP guidelines and other international regulatory requirements, as applicable.
3. GMP audit experience in the pharmaceutical industry.
4. Third-level degree qualification in a Science, Technical, or related discipline.
If this role interests you, please apply now!
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