GMP Manufacturing Unit Compliance Specialist
18 hours ago
Estimated Salary: £55,000 - £70,000 per annum.
We are seeking an experienced GMP Manufacturing Unit Compliance Specialist to join our team at MAC Clinical Research. As a key member of our GMP Team in Leeds, West Yorkshire, you will be responsible for ensuring compliance of the Manufacturing Unit with EU GMP regulations.
The successful candidate will have a strong background in Good Manufacturing Practice (GMP) and experience in a leadership role. You will be responsible for training production staff, liaising with staff and stakeholders, and ensuring compliance with EU GMP regulations.
Responsibilities:- Ensure compliance of the Manufacturing Unit with EU GMP.
- Approve production operations instructions and ensure their strict implementation.
- Evaluate and sign production records before sending them to the Quality Control Department.
- Ensure required initial and continuing training of department personnel is carried out.
About MAC Clinical Research:
We are a full-service global Contract Research Organisation (CRO) with a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.
Requirements:- Good knowledge of GMP and Good Clinical Practice.
- Experience in validation and working in an aseptic environment.
- 5 years previous experience in a leadership role.
- Clinical trials experience.
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