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Senior Pharmaceutical Services Specialist

2 months ago

Harrow, United Kingdom Parexel Full time
About the Role

We are seeking a highly skilled Senior Pharmaceutical Services Specialist to join our team at Parexel's Early Phase Clinical Unit. As a key member of our team, you will be responsible for assisting in the set-up and conduct of Phase I studies within the Pharmaceutical Services area.

Key Responsibilities
  • Study Set-up and Management: Maintain drug accountability records in accordance with agreed protocols and the principles of International Conference on Harmonization Good Clinical Practice and Good Manufacturing Practice.
  • Study Activities: Set-up and manage assigned studies from a pharmacy perspective, ensuring smooth delivery of study drug for clinical execution.
  • Departmental Leadership: Act as departmental study lead and set-up study activities, ensuring compliance with regulatory requirements and Standard Operating Procedures.
  • Documentation and Quality Assurance: Check (or prepare if required) batch documentation relating to subject dose assembly, packaging, labeling, and dispensing of Investigational Medicinal Product.
  • IMP Assembly and Dispensing: Participate in the assembly or dispensing of IMP and study-related drug following approved preparation/dispensing instructions.
  • Process Improvement: Implement Process Quality Standards and tasks assigned, and participate in the review of SOPs or working practices.
  • Housekeeping and Support: Responsible for routine housekeeping and assist with study audits as and when required.
  • Team Support: Assist and support the Production Manager and deputize during absence.
Requirements
  • Experience: A wealth of post-qualification experience within the Pharmaceutical Industry, CRO, Phase 1 Unit, or Hospital Pharmacy, working within Quality Assurance, Clinical Trial Packaging/Manufacture.
  • Skills: Excellent communication, team player, and organizational skills, with adaptability and flexibility. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
  • Education: Degree in Pharmacy/Pharmaceutical Science, or other life science.
What We Offer

Parexel is a leading global biopharmaceutical services company. We offer a dynamic and challenging work environment, with opportunities for professional growth and development.