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Job Location | Braunton |
Education | Not Mentioned |
Salary | Salary negotiable |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent , full-time |
Job Title: Qualified PersonSalary: DOELocation: BrauntonAcorn by Synergie have an exciting opportunity for a Qualified Person to join a busy team based in Braunton.The successful candidate will be responsible for driving compliance to Medicines and Healthcare products Regulatory Agency (MHRA) and Company requirements.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:* Educated to degree level in scientific subject or equivalent qualification and be eligible to act as Qualified Person.* 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.If you feel your experience can fulfil this role and you are interested in working for a fantastic company, please apply online today or call for a confidential chat.Acorn by Synergie acts as an employment agency for permanent recruitment.
Keyskills :
Qualified Person