Lead Specialist in Pharmaceutical Services
4 weeks ago
Our shared values empower us to achieve remarkable outcomes.
We are seeking a Lead Specialist in Pharmaceutical Services to contribute to our Early Phase Clinical Unit. This role requires extensive experience in the Pharmaceutical sector, Clinical Research Organizations (CROs), or Hospital Pharmacy, particularly in the realm of Clinical Trial Packaging and Manufacturing.
As a Senior Clinical Trial Services Expert, your responsibilities will include supporting the establishment and execution of Phase I studies within the Pharmaceutical Services domain, adhering to Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and local regulatory standards along with relevant Standard Operating Procedures (SOPs). You will also assist in the preparation and dispensing of Investigational Medicinal Products (IMPs) as necessary, ensuring compliance with GMP.
Key Responsibilities:
Maintain accurate drug accountability records in line with established protocols and the principles of International Conference on Harmonization Good Clinical Practice and Good Manufacturing Practice. Oversee and manage assigned studies from a pharmacy perspective, ensuring the seamless delivery of study medications for clinical execution. Act as the departmental lead for studies, coordinating all related activities. Review or prepare batch documentation associated with subject dose assembly, packaging, labeling, and dispensing of IMPs. Participate in the assembly or dispensing of IMPs and study-related medications following approved procedures. Implement the Quality Management System and participate in the review of SOPs or operational practices. Ensure routine housekeeping responsibilities are fulfilled. Assist with study audits as required. Support the Production Manager and act in their absence. Provide training to Pharmaceutical Service Specialists.Required Skills:
Strong communication skills, a collaborative spirit, and excellent organizational abilities. Flexibility and adaptability in a dynamic environment. Exceptional interpersonal, verbal, and written communication skills. A client-focused approach to all tasks. A willingness to embrace new learning opportunities and adapt to varied work assignments. Ability to manage multiple tasks with enthusiasm while prioritizing workload with meticulous attention to detail. Commitment to teamwork and collaboration in a matrix environment.Knowledge and Experience:
Extensive post-qualification experience in the Pharmaceutical sector, CROs, or Hospital Pharmacy, particularly in Quality Assurance and Clinical Trial Packaging/Manufacturing. Proficient in handling, managing, and dispensing Clinical Trial Supplies. Experience in aseptic reconstitution and manufacturing activities. Familiarity with Clinical Trial Supplies, including Manufacturing, Packaging, and Distribution. Experience in creating and reviewing batch documentation for the Manufacturing, Packaging, and Distribution of IMPs. Knowledge of EU QP certification and the release process for IMPs. Experience in GMP and GCP auditing.Educational Background:
A degree in Pharmacy, Pharmaceutical Science, or a related life science field.-
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