Job Description
We have an exciting new opportunity to join the GSTT pharmaceutical manufacturing unit as our expert pharmaceutical microbiologist.
Managing a small team of pharmaceutical microbiology staff, overseeing the environmental microbiological service provided to the manufacturing units across the trust and overseeing the contract laboratories utilised for testing not currently completed on site.
We are looking for an experienced individual ready to take on the challenge of updating and expanding our in house microbiological capabilities to meet the needs of our diverse product range (terminally sterilised, aseptic fill, nonsterile oral solid and liquid dosage forms). Upskilling and training the team and manufacturing staff in best microbiological practices and ensuring our policies, procedures and contamination control strategy are fit for purpose and adequately maintained.
Experience in working in a licensed manufacturing facility, being an SME for microbiology is desirable with experience of participation in regulatory inspections and presentation of data, reports and trending.
- To lead and manage Pharmaceutical Microbiology Team staff to plan and manage resources so that environmental monitoring and related microbiological testing meets regulatory requirements.
- To lead the Pharmacy’s Contamination Control Management Team in order to advise Quality and Pharmacy management of any risks that may impact the ability of NHS Pharmacy production units to operate to cGMP and contamination control in order to drive continuous improvement and compliance with industry best practice and regulatory requirements.
- Monitoring and trending of environmental monitoring and pharmaceutical water systems data and initiate corrective and preventative action accordingly.
- Provide technical advice and recommend actions to manufacturing units for the resolution of microbiological OOS, adverse trends, discrepancies and process changes / Change Control.
Guy’s & St Thomas NHS Foundation Trust Guy’s and St Thomas’ NHS Foundation Trust comprises five of the UK’s best known hospitals – Guy’s, St Thomas’, Evelina London Children’s Hospital, Royal Brompton and Harefield – as well as community services in Lambeth and Southwark, all with a long history of high quality care, clinical excellence, research and innovation.
We are among the UK’s busiest, most successful foundation trusts. We provide specialist care for patients including heart and lung, cancer and renal services as well as a full range of local hospital and community services for people in Lambeth and Southwark.
We have a long tradition of clinical and scientific achievement and – as part of King’s Health Partners – we are one of England’s eight academic health sciences centres, bringing together world-class clinical services, teaching and research. We have one of the National Institute for Health Research’s biomedical research centres, established with King’s College London in 2007, as well as dedicated clinical research facilities.
We have around 22,700 staff, making us one of the largest NHS Trusts in the country and one of the biggest employers locally. We aim to reflect the diversity of the communities we serve and continue to develop new and existing partnerships with local people, patients, neighbouring NHS organisations, local authorities and charitable bodies and GPs.
Refer to Job Description for full details of the role
Includes:
- To provide specialist microbiology input and review of pharmaceutical water system, environmental monitoring, process simulation/media fill and environmental monitoring excursion / deviation data and reports for adverse trends in liaison with the Contamination Control Management Team and initiate corrective and preventative action accordingly.
- Review cleanroom operator behavior and aseptic practices in manufacturing facilities to ensure the approach taken is in line with industry best practice and meets regulatory requirements.
- To provide specialist microbiology and contamination control training to personnel involved in cGMP manufacturing activities and to staff within Pharmaceutical Microbiology Team, Engineering and QA departments.
- Provide specialist microbiology and contamination control input in design, changes to cleanroom design, pharmaceutical water systems and manufacturing process changes and be actively involved in associated validation and qualification.
- Maintain site Contamination Control Strategy and support implementation of continuous improvement initiatives in line with industry best practice and regulatory requirements.
- Management of sub-contract companies for outsourced microbiological testing and review of documentation provided.
- Management of Pharmaceutical Microbiology team’s compliance with Quality Management System and associated Key Performance Indicators (KPIs).
- To maintain up to date awareness of regulatory and scientific advances by attending training courses and meetings that contribute to the efficiency and effectiveness of staff training and working practices.
- To identify and implement improvements to work practices/procedures within the framework of regulations.
- Act as a Subject Matter Expert (SME) during MHRA Regulatory Inspections and NHS Quality Audits.
Finance
- To manage all budgets associated with the microbiology service including• All equipment and consumables utilized by the QA pharmaceutical microbiology team
- Submission of new and replacement equipment requests through the medical physics service.
- Internal GSTT and external commercial contract set up, quotations and ongoing management
- Management, ownership and reporting of all financial data for the microbiology service on a monthly basis to feed into the Associate Chief Pharmacist. This will then feed in to reporting at pharmacy directorate review meetings.
- External contract laboratory contract management, tendering and review in collaboration with trust procurement services and the Head of Pharmaceutical Quality.
Other
- Ability to travel when required by the needs of the role, particularly between both NHS Guy’s and St Thomas’ hospital production units.
- Computer literate in Microsoft. Experience in electronic QMS or Environmental Monitoring data management programs would be beneficial but not essential.
- Good communication and interpersonal skills with a proven record in influencing and delivering change.
- Good organisational skills with a proven record of managing multiple activities concurrently.
- High level of attention to detail.
- Strong technical writing skills with a methodical approach to Root Cause Analysis investigation reporting and in creating and completing documentation.
- Ability to work within a cleanroom environment.
- The above is only an outline of the tasks, responsibilities and outcomes required of the role. You will carry out any other duties as may reasonably be required by the Quality or Pharmacy management.