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Pharmaceutical Services Specialist
2 months ago
We are seeking a highly skilled Pharmaceutical Services Specialist to join our team at Parexel. As a key member of our Clinical Trials team, you will play a critical role in the conduct of Phase I studies within our Pharmaceutical Services area.
Key Responsibilities- Maintain accurate and detailed records of drug accountability in accordance with ICH Good Clinical Practice and Good Manufacturing Practice guidelines.
- Prepare production worksheets and labels for assembly activities, ensuring compliance with regulatory requirements.
- Participate in the assembly and dispensing of Investigational Medicinal Products (IMPs) in accordance with written instructions and GMP guidelines.
- Manage assigned studies, including Pharmacy set up and delivery from start to end.
- Ensure controlled storage of all drugs and materials sourced or supplied by sponsors for use in clinical trial studies.
- Maintain PS facilities (Assembly and storage areas) in compliance with regulatory requirements.
- Assist with investigation of quality incidents and deviations, ensuring corrective actions are completed.
- Support audits (internal/external) in accordance with GMP guidelines.
- Preferably experience 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) and batch assembly/manufacturing of IMP/NIMP.
- Injection/infusion preparation experience and aseptic skill advantageous.
- Excellent communication skills and attention to detail.
- Ability to work effectively in a team environment.
- Adaptability and flexibility in a fast-paced environment.
- Degree in Pharmacy, Pharmaceutical Science, Biology, Chemistry, or life science.
