Senior Pharmaceutical Services Specialist
Harrow, Middlesex, United Kingdom Job ID R0000025148 Category Clinical TrialsAbout this Role
Come and join our team at Parexel’s Early Phase Clinical Unit in Harrow as a Senior Specialist in Pharmaceutical Services based at Northwick Park Hospital. You must have post qualification experience within the Pharmaceutical Industry, CRO, Phase 1 Unit, Hospital Pharmacy, or the Pharmaceutical Industry, working within Clinical Trial Packaging/ Manufacture.
As a Senior Pharmaceutical Services Specialist, you will assist in the set-up and conduct of Phase I studies within Pharmaceutical Services area in accordance with Good Manufacture Practice (GMP), Good Clinical Practice (GCP) and following local regulatory requirements and relevant Standard Operating Procedures (SOP’s). When required 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:
- 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
- To set-up and manage assigned study from Pharmacy perspectives and ensure smooth delivery of study drug for clinical execution
- Act as departmental study lead and set-up study activities
- Check (or prepare if required) batch documentation relating to subject dose assembly, packaging, labeling and dispensing of IMP
- If required, participate in the assembly or dispensing of IMP and study related drug following approved preparation / dispensing instruction
- Implement PQS and tasks assigned and participate in the review of SOP or working practice.
- Responsible for routine housekeeping
- Assist with study audit as and when required
- Assist and support Production Manager and deputises during absence
- Training Pharmaceutical Service Specialist
Skills:
- Must be a good communication, team player and well organised
- Adaptability and flexibility
- Excellent interpersonal, verbal and written communication skills
- Client focused approach to work
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Willingness to work in a matrix environment and to value the importance of teamwork
Knowledge and Experience:
- A wealth of post qualification experience within the Pharmaceutical Industry, CRO, Phase 1 Unit or Hospital Pharmacy working within Quality Assurance, Clinical Trial Packaging/ Manufacture
- Experience with handling, managing and dispensing Clinical Trial Supplies
- Experience with aseptic reconstitution /manufacturing activity
- Experience with Clinical Trial Supplies (Manufacture, Packaging and Distribution)
- Experience with batch documentation creation and review for Manufacturing, Packaging and Distribution of IMPs
- Experience with EU QP certification and release of IMP
- GMP and/ GCP auditing experience
Education:
- Degree in Pharmacy/ Pharmaceutical Science/ or other life science
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