Clinical Production Specialist

3 days ago


Leeds, Leeds, United Kingdom MAC Clinical Research Full time

At MAC Clinical Research, we prioritize integrity and honesty to drive groundbreaking contributions to human health.

We are seeking a seasoned Clinical Production Specialist to join our dynamic GMP Team in Leeds, West Yorkshire, UK.

Focusing on Quality
  • The successful candidate will be responsible for leading, delivering, and evaluating comprehensive production services, including aseptic services.
  • They will ensure that these services meet industry standards and collaborate with various stakeholders, including Medical Directors and Project Managers.
Key Requirements
  • A minimum of 5 years of leadership experience in clinical trials, with proven knowledge of Good Manufacturing Practice and Good Clinical Practice.
  • Experience in validation and working in an aseptic environment is crucial for this position.
Responsibilities
  • Ensure the Manufacturing Unit complies with EU GMP regulations and maintains plant hygiene standards.
  • Evaluate and approve production operations, ensuring strict implementation of regulatory requirements.
  • Monitor and control manufacturing environments, overseeing supplier and contract manufacturer approvals, and managing storage conditions for materials and products.
  • Maintain professional qualifications, adhering to MAC's health and safety policy, equality and diversity policy, and data protection standards.
What We Offer
  • A competitive salary of £70,000 - £90,000 per annum, reflective of pharmaceutical industry standards.
  • Health insurance and free onsite parking are included.
  • An annual leave package provides a great work-life balance.


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