GMP Manufacturing Unit Compliance Specialist

18 hours ago


Leeds, Leeds, United Kingdom MAC Clinical Research Full time
GMP Manufacturing Unit Compliance Specialist

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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