Pharmaceutical Services Specialist

3 days ago


King of Prussia, Pennsylvania, United States Parexel International Corporation Full time

Job Summary

We are seeking a highly skilled Pharmaceutical Services Specialist to join our team at Parexel International Corporation. As a key member of our Phase I studies team, you will be responsible for assisting in the conduct of clinical trials within our Pharmaceutical Services area.

Key Responsibilities

  • Maintain accurate records of drug accountability in accordance with ICH Good Clinical Practice and Good Manufacturing Practice.
  • Create and review master and production worksheets and labels for assembly activities.
  • Ensure the controlled storage of all drugs and materials sourced or supplied by sponsors for use in clinical trial studies.
  • Assist with the investigation of quality incidents and deviations, and ensure corrective actions are completed.
  • Participate in audits (internal/external) to ensure compliance with GMP.

Requirements

  • Degree in Pharmacy, Pharmaceutical Science, Biology, Chemistry, or a related life science.
  • Experience within the Pharmaceutical Industry, CRO, Phase 1 Unit, or Hospital Pharmacy.
  • Experience with Clinical Trial Supplies (manufacture and packaging) and batch assembly/manufacturing of IMP/NIMP.

What We Offer

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


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