Pharmaceutical Services Specialist
4 weeks ago
As a Pharmaceutical Services Specialist at Parexel International Corporation, you will play a key role in the conduct of Phase I studies within our Pharmaceutical Services area. You will assist in the assembly and dispensing of Investigational Medicinal Products (IMPs) in accordance with ICH Good Clinical Practice (GCP) and local regulatory requirements. Your attention to detail and ability to work in a team will be essential in ensuring the quality and compliance of our operations.
Key Responsibilities
- Maintain accurate and up-to-date drug accountability records in accordance with agreed protocols and GCP principles.
- Create and review master and production worksheets and labels for assembly activities.
- Ensure the controlled storage of all drugs and materials sourced or supplied by sponsors for use in clinical trial studies.
- Ensure our Pharmaceutical Services facilities are maintained in compliance with regulatory requirements.
- Maintain equipment lists and ensure calibration and preventive maintenance are performed.
- Assist with the investigation of quality incidents and deviations, and ensure corrective actions are completed.
- Assist with audits (internal and external) to ensure GMP compliance.
Requirements
- Degree in Pharmacy, Pharmaceutical Science, Biology, Chemistry, or a related life science.
- Experience within the Pharmaceutical Industry, CRO, Phase 1 Unit, or Hospital Pharmacy.
- Experience with Clinical Trial Supplies (manufacture and packaging) and batch assembly/manufacturing of IM/NIMPs.
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