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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.

Pharmaceutical Services Specialist

Job ID 67565BR Harrow, England, United Kingdom
As a Pharmaceutical Services Specialist, you will assist in the conduct of Phase I studies within Pharmaceutical Services area in accordance with ICH Good Clinical Practice (GCP) and following local regulatory requirements and relevant Standard Operating Procedures (SOP’s). You will assist and participate in the assembly /dispensing of Investigational Medicinal Product (IMP) in accordance with written instruction and in compliance with Good Manufacturing Practice (GMP).


Key Accountabilities


  • Maintain drug accountability records in accordance with agreed protocols and the principles of International Conference on Harmonization Good Clinical Practice and Good Manufacturing Practice (Assembly (Manufacture, Packaging and Dispensing) of drugs in accordance with written instruction and in compliance with GMP.
  • Create and review master and production worksheets and labels for assembly activities.
  • Ensure controlled storage of all drugs (including controlled drugs, licensed drugs and unlicensed drugs) and materials sourced or supplied by sponsors for use in clinical trial studies.
  • Ensure PS facilities (Assembly and storage areas) are maintained in compliance with regulatory requirements
  • Maintain equipment list and ensure calibration and/ PPM is performed
  • Assist with investigation of quality incidents and deviations and ensuring corrective actions are completed.
  • Assist with audits (internal/ external) GMP).

Qualifications

Skills
  • Great communication skills.
  • Good attention to detail.
  • Enjoy working in a team.
  • Adaptability.
Education
  • Degree in Pharmacy, Pharmaceutical Science, Biology, Chemistry or life science.

Minimum Work Experience
  • Experience within the Pharmaceutical Industry, CRO, Phase 1 Unit or Hospital Pharmacy.
  • Experience with Clinical Trial Supplies (Manufacture and Packaging)
  • Experience with batch assembly/ manufacturing of IMP/NIMP.

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