QA Senior Specialist - Compliance
- Dublin
- Contract
- Full-time
- Review and approve quality agreements.
- Release incoming materials for use in manufacturing operations
- Support qualification of new suppliers/materials and requalification of existing.
- Assess supplier change notifications for impact to qualification status.
- Support material certification and direct dispense programs.
- Review and approve quality agreements.
- Authoring, review and approval of QA-related procedures.
- Support OpEx programs and champion continuous quality improvement initiatives.
- QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:
- Change controls
- Deviations/Investigations
- CAPAs
- Other associated documentation
- BSc in Science or related discipline with a minimum of 2 years' Supplier Quality or related experience in a Biologics or Pharmaceutical environment.
- A clear understanding of cGMP requirements for QA systems and compliance and/or manufacturing.
- Detailed knowledge of Biologics Processing would be a distinct advantage.
- Required to work on his/her own initiative in addition to working as part of a team.
- Excellent communication, presentation, time-management and organizational skills are essential.