Pharmaceutical Services Specialist

Employer
Parexel
Location
Harrow, United Kingdom
Salary
Competitive
Start date
11 Sep 2023
Closing date
11 Oct 2023

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

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


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

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Find Us
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
 Uxbridge
Middx
UB8 1LZ
GB
Apply on website
Send job
Apply on website

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