Quality Assurance Manager
2 days ago
Senior Quality Assurance Specialist Compliance
Description:The successful candidate will be responsible for ensuring the highest quality standards are met in our manufacturing operations. This includes reviewing and approving quality agreements, releasing incoming materials for use in manufacturing, and supporting qualification of new suppliers/materials.
The ideal candidate will have a strong understanding of cGMP requirements for QA systems and compliance, as well as experience working in a Biologics or Pharmaceutical environment. Excellent communication, presentation, time management, and organisational skills are essential.
Responsibilities:- Review and approve quality agreements
- Release incoming materials for use in manufacturing operations
- Support qualification of new suppliers/materials
- Assess supplier change notifications for impact to qualification status
- Support material certification and direct dispense programs
- Authoring, review, and approval of QA-related procedures
- Support OpEx programs and champion continuous quality improvement initiatives
- 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
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