Production Pharmacist Aseptics Specialist
4 weeks ago
Job Summary
We are seeking an experienced pharmacist to lead our aseptic services team at Guy's and St Thomas' NHS Foundation Trust. The successful candidate will have a strong background in aseptic services and quality management, with experience in managing change and deviations within a pharmaceutical quality management system.
Main Responsibilities
- Act as an authorised pharmacist responsible for the provision of CIVAS, trials, advanced therapies and PN products prepared and released under Section 10 exemption.
- Manage the day-to-day operation of the aseptic unit, working collaboratively with staff in the unit and wider pharmacy and clinical teams.
- Ensure service delivery meets the needs of our patients.
- Ensure the requirements of the site quality management system are complied with as required by the Quality Assurance of Aseptic Preparation Services (QAAPS), national and NHS guidance.
- Work with the Clinical Trials team in delivering clinical trials for GSTT and commercial sponsored trials to ensure full preparation and clinical regulatory compliance.
About Us
Guy's and St Thomas' Technical Services has one of the country's largest manufacturing facilities, split across a number of sites and involves around 140 staff working in licensed manufacturing and named patient dispensing areas. Services include aseptic preparation of CIVAS and chemotherapy, sterile and non-sterile manufacturing, clinical trials, quality control and quality assurance.
We have cultivated a culture that actively promotes patient safety as a top priority. This ethos is ingrained in our team's values and everyday practices, fostering an environment where every member is committed to upholding the highest standards of care.
Person Specification
Essential
- Previous assessable experience of working as a pharmacist with experience as an authorised pharmacist within an aseptic unit.
- Previous assessable experience in staff training and assessment
Desirable
- Previous assessable experience in CIVAS, chemotherapy, PN, ATMPs or sterile/non-sterile manufacturing
Knowledge/Qualifications
Essential
- Masters degree MPharm
- Certificate in clinical Pharmacy Practice or equivalent
- Competency assessed and examined professional registration as a pharmacist with the GPhC (1 year)
Desirable
- Specialist higher degree (Masters) in Technical Services (Pharmaceutical Technology & Quality Assurance MSc) or working towards
- Specialist higher degree (Masters) or Diploma in clinical Pharmacy Practice
Skills
Essential
- Practical knowledge of GMP, QA and all current relevant regulations
- Ability to organise own time and the time of others
- Experience of managing change and deviations within a pharmaceutical quality management system
- Demonstrated ability to risk assess and investigate deviations and errors
Desirable
- Ability to apply the principles of GCP and GMP to the running of clinical trials
- Ability to undertake the day to day management, motivation and appraisal of staff
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