ABOUT THIS ROLE

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

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