Pharmaceutical Services Specialist

4 weeks ago


King of Prussia, Pennsylvania, United States PAREXEL Full time

Job Summary

We are seeking a highly skilled Pharmaceutical Services Specialist to join our team at PAREXEL. As a key member of our Pharmaceutical Services team, you will play a critical role in the conduct of Phase I studies, ensuring compliance with ICH Good Clinical Practice (GCP) and local regulatory requirements.

Key Responsibilities

  • Maintain accurate and detailed records of drug accountability, adhering to agreed protocols and principles of International Conference on Harmonization Good Clinical Practice and Good Manufacturing Practice.
  • Create and review master and production worksheets and labels for assembly activities, ensuring compliance with regulatory requirements.
  • Ensure the 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 that Pharmaceutical Services facilities, including assembly and storage areas, are maintained in compliance with regulatory requirements.
  • Maintain equipment lists and ensure calibration and preventive maintenance are performed.
  • Assist with the investigation of quality incidents and deviations, ensuring corrective actions are completed.
  • Assist with audits, including internal and external GMP audits.

Requirements

  • Degree in Pharmacy, Pharmaceutical Science, Biology, Chemistry, or a life science.
  • 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.

What We Offer

  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive compensation package.


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