Qualified Person

**Description Overview**:
We have an exciting opportunity for a Qualified Person to join the team based in Braunton, North Devon. This is really key role to support our business as we continue to progress and grow.
In your role, you will be responsible for driving compliance to Medicines and Healthcare products Regulatory Agency (MHRA) and Company requirements/standards by collaborating with multifunctional teams and providing quality leadership, as required, to achieve GMP compliance plus process effectiveness and efficiency.

You’ll ensure that key tasks, projects and improvement initiatives are driven to completion, while effectively managing the expectations of line management, peers, subordinates internal and external customers. Undertaking QP certification, Technical Release, and Batch Release are key components of your role.

**Scope of the Role**:

- Release of Batches.
- Support operations with ad-hoc queries.
- Deviation support for manufacturing, working with process owners and operational teams.
- Attend relevant operational meetings.
- BMR & BPR approval.
- 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 (if detailed on site MIA (IMP)
- Risk management - preparation of risk assessments covering deviations concerning raw materials, bulk manufacture, equipment and facilities etc.
- Review and approval of relevant documentation, including Technical Agreements, as required.
- Review/Approval SAP Change Controls Technical and Quality Events, plus OOS Investigation Reports
- Review/approval of validation protocols and reports - process, equipment, facility, cleaning & computer systems.
- Deputise for the Quality Systems Manager, Quality Engineering Manager and other Qualified Persons as required.

**Experience Required**:

- Experienced within the pharmaceutical/healthcare industry.
- Demonstrate knowledge of pharmaceutical manufacture and an excellent understanding of GMPs.
- Ideally you will have some supervisory experience.
- You are an effective communicator - both written and verbal, and you can convey information positively, succinctly and objectively.
- You are a strong team player and can work as part of a team to find win/win solutions to issues. Building relationships with senior personnel, peers and subordinates effortlessly, is essential to success in this role.
- Coach, mentor, develop team members to encourage and support a high-performance work culture and behaviours.
- Ability to plan and organise workload to ensure that commitments are seen through to the end, fully documented.