As a Pharmaceutical Services Specialist, you will assist in the conduct of Phase I studies within the 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 participate in the assembly /dispensing of Investigational Medicinal Product (IMP) in accordance with written instruction and in compliance with Good Manufacturing Practice (GMP).
You will also manage assigned studies and are responsible for Pharmacy set up and delivery from start to end.
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
* Prepare production worksheets and labels for assembly activities
* Participate in IMP assembly activity
* Responsible for assigned housekeeping tasks
* Responsible for Pharmacy set up and delivery for assigned studies
* 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
* Assist with investigation of quality incidents and deviations and ensuring corrective actions are completed.
* Assist with audits (internal/ external) GMP
Knowledge, Skills & Experience
* Preferably experience of working within the pharmaceutical industry, a Clinical Research Organization (CRO), Phase 1 clinical trial unit, or a hospital pharmacy setting.
* Experience with Clinical Trial Supplies (Manufacture and Packaging)
* Experience with batch assembly/ manufacturing of IMP/NIMP
* Injection/infusion preparation experience and aseptic skills advantageous
* Great communication skills
* Must have good attention to detail
* Enjoy working in a team
* Adaptability
Education
* Degree in Pharmacy, Pharmaceutical Science, Biology, Chemistry, or life science
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