GMP Production Manager

3 weeks ago


Leeds, Leeds, United Kingdom MAC Clinical Research Full time
Job Title: GMP Production Manager

MAC Clinical Research is seeking a highly skilled and experienced GMP Production Manager to join our team in Leeds, West Yorkshire. As a key member of our GMP Team, you will be responsible for leading and delivering comprehensive production services, including aseptic services.

Key Responsibilities:
  • Ensure compliance with EU GMP regulations and guidelines.
  • Oversee the production and storage of products to ensure they meet quality standards.
  • Approve production instructions and ensure their implementation.
  • Review and sign production records before sending them to the Quality Control Department.
  • Monitor and maintain the manufacturing environment, equipment, and premises.
  • Ensure equipment and process validations are carried out to GMP standards.
  • Provide initial and continuing training to department personnel.
  • Authorize written procedures and documents, including amendments.
  • Monitor and control the manufacturing environment, ensuring plant hygiene standards are maintained.
  • Approve and monitor suppliers of materials and contract manufacturers.
  • Designate and monitor storage conditions for materials and products.
  • Responsible for paper documentation and electronic record retention.
  • Monitor compliance with good manufacturing practice requirements.
  • Participate in management reviews of process performance, product quality, and the quality management system.
  • Ensure a timely and effective communication and escalation process for quality issues.
  • Comply with MAC's health and safety policy and equality and diversity policy.
  • Maintain professional qualifications and continuous personal development.
  • Work according to current data protection standards and practice good information management.
Requirements:
  • Good knowledge of Good Manufacturing Practice.
  • Good knowledge of Good Clinical Practice.
  • Experience in validation.
  • Familiarity with working in aseptic environments.
  • 5 years of previous experience in a leadership role.
  • Clinical trials experience.
Benefits:
  • Competitive salary in line with pharmaceutical industry standards.
  • Health Insurance.
  • Free onsite parking.
  • 25 days annual leave (increasing to 30 days after 6 years' service).
  • Your birthday off work.

MAC Clinical Research is committed to investing in its employees and providing opportunities for career growth and development. If you are a motivated and experienced professional looking to join a dynamic team, please submit your application.



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