Pharmaceutical Microbiologist

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