Pharmaceutical Services Specialist,

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 (SOPs).

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:

1. Maintain drug accountability records in accordance with agreed protocols and the principles of International Conference on Harmonization Good Clinical Practice and Good Manufacturing Practice.
2. Create and review master and production worksheets and labels for assembly activities.
3. 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.
4. Ensure PS facilities (Assembly and storage areas) are maintained in compliance with regulatory requirements.
5. Maintain equipment list and ensure calibration and PPM is performed.
6. Assist with investigation of quality incidents and deviations and ensuring corrective actions are completed.
7. Assist with audits (internal/external) GMP.

Knowledge, Skills & Experience:

1. Experience within the Pharmaceutical Industry, CRO, Phase 1 Unit, or Hospital Pharmacy.
2. Experience with Clinical Trial Supplies (Manufacture and Packaging).
3. Experience with batch assembly/manufacturing of IMP/NIMP.
4. Injection/infusion preparation experience and aseptic skill advantageous.
5. Great communication skills.
6. Must have good attention to detail.
7. Enjoy working in a team.
8. Adaptability.

Education:

1. Degree in Pharmacy, Pharmaceutical Science, Biology, Chemistry, or life science.