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Clinical Trials Specialist – Pharmacy Manufacturing Unit
4 months ago
Job summary
The Pharmacy Manufacturing Unit (PMU) at Guy's Hospital is looking for self motivated and proactive individual with Clinical Trial experience to join our production team and support the delivery and maintenance of our Investigational Medicinal Product (IMP) manufacture service.
The successful candidate will have a proven track record of setting up & managing clinical trials in a pharmacy technical services environment as well as a continuous improvement mindset to ensure the service we deliver to our research partners is of the highest standard.
Main duties of the job
To be responsible for supporting the delivery of the PMU Clinical Trials service within the GMP and GCP legislative framework. To provide expert input into all aspects of the Clinical Trial process from liaising with Sponsors, set up and manufacture of IMP, coordinating IMP supply and eventual closure and archiving of the trial To be responsible for ensuring the requirements of the production area's quality management system are maintained and developed as required by the MS(specials), MIA(IMP) licenses and NHS guidance. To deputise for the Senior Production Pharmacist - Clinical Trials in their absence. To act as a professional and technical role model for clinical trials within the Production Unit
About us
The Pharmacy Manufacturing Unit (PMU) at Guy's Hospital is an MHRA licensed unit, manufacturing a broad portfolio of Specials (unlicensed) medicines and extemporaneously prepared products. These include non-sterile oral liquids & suspensions, tablets, capsules, creams & ointments and terminally sterilized parenteral solutions, topical gels and eye drops. Additionally, under our MIA(IMP) License, the PMU provides clinical trial manufacturing activities through our collaboration with Kings Health Partners and other clinical trial organizations.
Job description
Job responsibilities
Please see Job description for full details
Service Delivery
To coordinate with the Senior Operational Lead regarding preparation of Clinical Trial medicines to ensure a safe and efficient service. To ensure that all IMP activities undertaken within the Production Unit comply with GMP/GDP/GCP, Health and Safety and COSHH legislation and that all work documentation and procedure manuals meet these regulations. To support senior staff in the day-to-day management of clinical trials staff and workload in the allocated preparation area. To ensure that all staff working on Clinical Trials in Production are trained and competency assessed in the tasks they undertake.Clinical trials
To lead on the set-up and implementation of Clinical Trials requiring preparation or manufacture to ensure GMP, GCP, full protocol, CTA, and IMPD compliance. To generate quality technical agreements, commercial and supply agreements in response to acceptance of a clinical trial, liaising regularly with the trial sponsor. To generate or contribute to the continued maintenance of trial specific IMPDs in liaison with the local site QA, QP, QC department and trial sponsor. To lead on generation of batch specific documentation such as training logs, batch manufacturing records and any other required trial specific documentation. To supervise the clinical trials co-ordinator and clinical trials workload on a day to day basis and report regularly on the status of clinical trials to the production manager highlighting any resource requirements. To oversee the manufacture of clinical trials and training on trial specific protocols and manufacturing methods to ensure other staff are aware of the trial-specific requirements of the batch/product. To supervise trainee pharmacists, STP students and trainee Production technicians when rotating through Production Clinical Trials. To ensure effective communication is maintained with clinical trial sponsors and/or contract partners for any aspect of the Production Clinical Trial service delivery. To be responsible for ensuring all Clinical Trial Site Master Files are updated and maintained contemporaneously in accordance with data integrity principles to be audit ready at all times.Governance and Quality
To ensure that the Clinical Trial Pharmaceutical Quality Management system is maintained and developed in accordance with the MS(Specials) and MIA(IMP) license requirements and in response to changes in regulations and legislation. To undertake a regular review of all quality exceptions according to department procedures. To author and review deviation reports and change controls along with other PQS documents and assist in risk-based decision making on product quality and final product disposition from a production perspective in liaison with QA and the QP. To support and document change through the Quality Management System to both reduce risk and drive innovation in clinical trial activities and the overall clinical trials service. To ensure all changes to the Quality Management System are effectively communicated via the change control process to all grades of staff. By example and effective communication to create an environment of quality improvement. To review and develop Standard Operating Procedures to ensure compliance with current and future clinical trial, manufacturing and regulatory requirements. To participate in sponsor or other customer related audits for clinical trials including agenda writing, ensuring appropriate staff are aware and present at the audit. To review with the QA team and QP any clinical trial related audit reports, draw up an action plan for compliance achievement and communicate appropriately with the auditor to ensure timely close out of items raised. To contribute to regulatory inspections involving the MIA(IMP) licence. To ensure that all staff are aware of the relevant Standard Operating Procedures, that these are well maintained and kept up to date with technological and regulatory updates to drive optimal performance of the clinical trials service.Training and Education
To induct all new staff to the department into the clinical trials service and introduce the clinical trials team members and their roles. To prepare activity competency records relevant to clinical trials related activities andassess staff competence in completing such activities. To regularly update the wider production and quality teams in new clinical trials / batches / products being introduced to the department through presentations and team meetings. To assist with the induction, training and assessment of staff working in the unit. Person Specification
Education & Qualifications
Essential
Masters degree in Science based discipline
Desirable
Masters degree in Pharmacy (MPharm) Post-graduate qualification relevant to Pharmaceutical manufacturing or portfolio that demonstrates the acquisition and use of an equivalent level of specialist pharmaceutical knowledge
Previous Experience
Essential
Previous experience of the set up and management of clinical trials in line with GMP & GCP Previous experience of IMP manufacture Previous evaluated experience of delivering induction and competency-based training
Desirable
Previous experience of Clinical Trial audit Demonstrated ability to manage a project and lead on objective completion Previous experience of Sterile and Non sterile pharmaceutical manufacturing under a MIA(IMP) Licence
Skills/Knowledge/Ability
Essential
Demonstrated practical knowledge of GCP, GMP, GDP, QA and relevant regulations. Demonstrated ability to critically review GMP documentation including batch records and standard operating procedures completed or created by others. Demonstrated ability to critically review GMP documentation including batch records and standard operating procedures completed or created by others. Demonstrated ability to manage clinical trial/study stock Demonstrated computer and IT skills including databases & pharmacy specific systems for building and managing products
Desirable
Demonstrated ability to manage a deviations, change control & CAPA as well as perform risk assessments & root cause analysis. Demonstrated ability to manage performance.