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Qualified Person

5 months ago

Braunton, United Kingdom Synergie Full time

Job Title: Qualified Person

**Salary**: DOE
Location: Braunton
Acorn by Synergie have an exciting opportunity for a Qualified Person to join a busy team based in Braunton.
Scope of the role:

- Release of Batches.
- Support operations with ad-hoc queries.
- Support for manufacturing, working with process owners and operational teams.
- Attend relevant operational meetings.
- API QP declarations and approval of audit reports.
- Review and approval of relevant documentation, including Technical Agreements, as required.
- Review/Approval SAP Change Controls Technical and Quality Events, plus OOS Investigation Reports.
- Attending the change control committee, and review and approve changes.
- Attending CAPA committee meetings.
- Attend Site Quality Council
- Site Qualified Person for Investigational Medicinal products
- Risk management - preparation of risk assessments covering deviations concerning raw materials, bulk manufacture, equipment and facilities etc.
Experience required:

- Experienced within the pharmaceutical/healthcare industry.
- Demonstrate knowledge of pharmaceutical manufacture and an excellent understanding of GMPs.
- Effective communicator - both written and verbal, and can convey information positively and objectively.
- Ability to plan and organise workload to ensure that commitments are seen through to the end, fully documented.
Acorn by Synergie acts as an employment agency for permanent recruitment.