Job summary
Band 8a Quality Control Pharmaceutical Microbiologist
The post is for a pharmaceutical microbiologist, specialising in microbiological contamination control to provide product quality and sterility assurance in accordance with regulatory and microbiological quality standards.
Reporting to the 8B QA/QC specialist, you will work with the QC laboratory technicians and other QA/QC staff, to develop and undertake pharmaceutical microbiology and other non-clinical microbiological work. The post holder will manage the QA/QC microbiology service and ensure environmental monitoring and associated microbiological testing is performed in accordance with schedules and meet regulatory requirements and manage the reporting system.
To lead on Contamination Control Strategies to identify and monitor progress on contamination control improvement initiatives for improved compliance in line with current best practice guidance and regulatory requirements.
To provide specialist microbiology advice and recommend actions to Pharmacy manufacturing units for the resolution of microbiological Out Of Specification (OOS), adverse trends, and discrepancies.
To assist in maintaining the integrated Quality systems across the Pharmacy Manufacturing Services as required by the licenses held which include the MS, MA(IMP), WDA(H) and Home office licenses in accordance with relevant UK and EU regulatory and NHS guidance.
Main duties of the job
On the Hampstead site we host one of the most extensive manufacturing suites in the NHS which supplies high quality bespoke products to both Primary and Secondary Care and Research organisations. The facility has an MHRA Manufacturer "Specials" Licence (MS), a Wholesale Distribution Authorisation (WDA(H)) and a Manufacturer Licence for Investigational Medicinal Products (Clinical Trials) (MIA(IMP)). At Barnet we have a manufacturing unit supplying products for Royal Free London patients.
About us
The Royal Free London NHS Trust is one of the largest in the UK, with around 10,000 staff serving 1.6 million patients. It comprises Barnet Hospital, Chase Farm Hospital, the Royal Free Hospital and more than 30 services in the community. This large scale organisation provides an unprecedented opportunity for us to continue our pioneering work, particularly in finding ways to deliver even better care to our patients. With many specialities including renal, liver, oncology, infectious disease, haemophilia and scleroderma which are underpinned by a strong research agenda, the Royal Free is renowned for providing excellent patient care.
The Pharmacy department is a friendly, progressive and expanding unit dedicated to providing the highest standards of pharmaceutical care and service across all three sites, with clinical teams across many different specialities including renal, liver, oncology, paediatrics, intensive care, medicine and surgery. The pharmacy department have recently played a pivotal role in the implementation of electronic prescribing system and have strategic plans for the development of more consultant and independent prescribing pharmacists.
Job description
Job responsibilities
1. MICROBIOLOGICAL RESPONSIBILITY
- To manage available resources to deliver a Pharmaceutical Microbiology service to ensure that environmental monitoring and related microbiological testing meets regulatory requirements.
- To lead in Pharmacy manufacturing units Contamination Control strategies, and to advise Quality and Pharmacy management of any risks that may impact the ability of the licensed manufacturing units to operate to cGMP and current contamination control and regulatory requirements.
- To drive continuous improvement to maintain compliance in line with best practice and regulatory requirements. Provide technical advice and recommend actions to relevant manufacturing units for the resolution of microbiological OOS, adverse trends, discrepancies, and process changes / Change Control
- To provide specialist microbiology input and review of data for; the pharmaceutical water system, environmental monitoring, process simulation/media fill and environmental monitoring excursion / deviation. Monitoring data, and generating reports for adverse trends, and initiate corrective and preventative action accordingly
- To review cleanroom operator behaviour and aseptic practices in manufacturing facilities to ensure the approach taken is in line with industry best practice and meets regulatory requirements
- To develop standard operating procedures for the microbiological section to meet requirement of GMP, GLP and COSHH and implement improvements to work practices/procedures within the framework of regulations and review appropriately.
- To ensure the instruments used in environment monitoring including incubators are maintained and calibrated per planned preventative maintenance (PPM) schedules, to ensure compliance with local and regulatory guidelines.
- To plan, organise and manage monitoring schedules. To lead in carrying out the environmental monitoring programme, in pharmacy clean rooms at the manufacturing units within the trust as well as where the laboratory provides a Quality Assurance service.
- To assist the Head of Quality and Quality Control Laboratory Manager in setting up Technical Agreements with internal and external clients.
- To assist in the maintenance and development of the Quality Management Systems across the Quality and Production departments, including but not limited to writing, reviewing and updating department procedures and policies and maintaining and developing the departments change control, deviation, complaints, recall and corrective action and preventative action (CAPA) systems.
- To ensure all necessary testing is carried out, according to the approved written specifications or Pharmacopeial monographs. To interpret standards and set warning and action limits for monitoring undertaken where appropriate based on results and trends.
- To be familiar with the chemical and microbiological testing carried out in the Quality Control Laboratory.
- Staff Supervision and Training
To provide specialist microbiology and contamination control training to personnel involved in cGMP manufacturing activities and to staff within Quality Team, and relevant personnel in line with current GMP guidelines, Health and safety, COSSH.
- To assist in managing staff assigned to the QA/QC Department including objective setting, performance, and attendance monitoring
- To review cleanroom operator behavior and aseptic practices in manufacturing facilities and advice on best practice to ensure the approach taken is in line with industry best practice and meets regulatory requirements.
- To provide specialist microbiology training to relevant personnel involved in cGMP activities including QC/QA, manufacturing, and external personnel as necessary.
- To be responsible for the microbiological competency checks of QC/QA Staff, and assessment before signing off Training Records.
- Act as a Subject Matter Expert (SME) during MHRA Regulatory Inspections and NHS Quality Audits.
3. Resource Management - To manage the procurement and stock control of microbiological media, reagents and consumables and ensure there is adequate supply of relevant media, proper stock rotation to assure optimal stock control and maintenance.
- To manage sub-contract companies for outsourced microbiological testing. To generate needed documentation to the contract laboratory. When necessary to dispatch samples for specific tests.
4. Research and Development (including Clinical Trials) - To provide support to the development, formulation and validation of new products in response to clinical trial and clinical need and risk management in accordance with client and trust objectives.
- To assist in the review of clinical trial documentation and assess whether the production of the Investigational medicinal product (IMP) comes under the MA (IMP) license. To ensure that all IMP production (licensed and unlicensed) follows the principle of GMP and GCP.
- To assist in the review and authorisation of IMP production documentation with microbiological testing requirement to ensure the preparation of the IMP complies with all regulatory requirements.
- To attend site visits by sponsors, clinical research organizations and their representatives to ensure that all pharmacy requirements for the undertaking of IMP production are available
- To lead in the response to audit deficiencies in a timely manner
- To assist in the critical assessment of current manufacturing methods with a view to improving the quality and efficiency of the manufacturing process.
- To undertake stability studies where required in line with current ICH guidelines or equivalent.
- To coordinate a rolling programme to investigate the validation and possible extension of current expiry dates attributed to manufactured batches.
- 5. CLINICAL SERVICES
- To assist in the provision of expert pharmaceutical QC/QA advice on the use of all the trusts manufactured products
- To assess the suitability of unlicensed medicines purchased by the trust and release for use as appropriate
- To assist in responding to MHRA drug alerts and coordinate retrieval, quarantine, and replacement of stock
- To assist in the temperature monitoring and mapping of relevant drug storage areas and communication of results and excursions to all relevant areas of the trust
6. PROFESSIONAL RESPONSIBILITIES
To remain on the relevant Professional register.
- To undertake GCP and GMP training as required.
- To maintain 100% MAST record.
- To act as a role model to all other Pharmacy staff.
- To always behave in a manner that is professional, positive and polite.
- To be accountable for own professional actions.
- To be responsible for ensuring that (s)he remains aware of current developments in pharmacy, human resources and employment law
- To be responsible for his/her own professional development and participate in own Performance and Development planning.
- To complete CPD where applicable.
- Business and Intellectual Property
- To ensure all research and development relating to new product testing is fully costed with respect to microbiological requirements.
- To help identify and manage issues of intellectual property
- Other Duties
To undertake other duties as requested by the Head of Pharmaceutical Quality Services and the Group Chief Pharmacist.
To contribute to pharmacy weekend, late duty and bank holidays rotas as required.
To work across all sites and other NHS production units when required.
GENERAL RESPONSIBILITIES
Infection Control
Infection control is everyones responsibility. All staff, both clinical and non clinical, are required to adhere to the Trusts Infection Prevention and Control policies and procedures and the Health Act (2006) Code of Practice for the prevention and control healthcare associated infections and make every effort to maintain high standards of infection control at all times thereby reducing the risk of Healthcare Associated infections.
It is the duty of every member of staff to take personal responsibility for the prevention and control of infection, as laid down in the Trusts polices and procedures which reflect the statutory requirements of the Hygiene Code.
- To work in close collaboration with the Infection Control Team.
- To ensure that monitoring of clinical practice is undertaken at the agreed frequency.
- To ensure that the ward environments are cleaned and maintained to the highest standards; ensuring that shortfalls are rectified, or escalate as necessary.
- To ensure that all relevant monitoring data and issues are provided to the Directorates Governance structures.
- To ensure that all staff are released to attend infection control-related educational sessions and staff with specialist roles, e.g. link practitioners, are released to undertake their duties.
Health and Safety at Work
The post holder is required to:
- Take reasonable care for the health and safety of himself/herself and other persons who may be affected by their actions or omissions at work.
- Co-operate with the employer in ensuring that all statutory and other requirements are complied with.
- To improve understanding of hazards specific to Aseptic service & COSHH materials and highlight ways of reducing risks to staff.
Location of work
The appointment is specifically not designated as being permanently in one place. The Trust reserves the right to require staff to work at such other places or locations as it considers reasonable and necessary on a temporary or more permanent basis
Pharmacy Services
The Pharmacy Services of the Royal Free London are constantly evolving to best meet the needs of patients and our healthcare colleagues and partners and this may lead to providing a full and comprehensive Pharmaceutical support over 7 days a week.
Job description
Job responsibilities
1. MICROBIOLOGICAL RESPONSIBILITY
- To manage available resources to deliver a Pharmaceutical Microbiology service to ensure that environmental monitoring and related microbiological testing meets regulatory requirements.
- To lead in Pharmacy manufacturing units Contamination Control strategies, and to advise Quality and Pharmacy management of any risks that may impact the ability of the licensed manufacturing units to operate to cGMP and current contamination control and regulatory requirements.
- To drive continuous improvement to maintain compliance in line with best practice and regulatory requirements. Provide technical advice and recommend actions to relevant manufacturing units for the resolution of microbiological OOS, adverse trends, discrepancies, and process changes / Change Control
- To provide specialist microbiology input and review of data for; the pharmaceutical water system, environmental monitoring, process simulation/media fill and environmental monitoring excursion / deviation. Monitoring data, and generating reports for adverse trends, and initiate corrective and preventative action accordingly
- To review cleanroom operator behaviour and aseptic practices in manufacturing facilities to ensure the approach taken is in line with industry best practice and meets regulatory requirements
- To develop standard operating procedures for the microbiological section to meet requirement of GMP, GLP and COSHH and implement improvements to work practices/procedures within the framework of regulations and review appropriately.
- To ensure the instruments used in environment monitoring including incubators are maintained and calibrated per planned preventative maintenance (PPM) schedules, to ensure compliance with local and regulatory guidelines.
- To plan, organise and manage monitoring schedules. To lead in carrying out the environmental monitoring programme, in pharmacy clean rooms at the manufacturing units within the trust as well as where the laboratory provides a Quality Assurance service.
- To assist the Head of Quality and Quality Control Laboratory Manager in setting up Technical Agreements with internal and external clients.
- To assist in the maintenance and development of the Quality Management Systems across the Quality and Production departments, including but not limited to writing, reviewing and updating department procedures and policies and maintaining and developing the departments change control, deviation, complaints, recall and corrective action and preventative action (CAPA) systems.
- To ensure all necessary testing is carried out, according to the approved written specifications or Pharmacopeial monographs. To interpret standards and set warning and action limits for monitoring undertaken where appropriate based on results and trends.
- To be familiar with the chemical and microbiological testing carried out in the Quality Control Laboratory.
- Staff Supervision and Training
To provide specialist microbiology and contamination control training to personnel involved in cGMP manufacturing activities and to staff within Quality Team, and relevant personnel in line with current GMP guidelines, Health and safety, COSSH.
- To assist in managing staff assigned to the QA/QC Department including objective setting, performance, and attendance monitoring
- To review cleanroom operator behavior and aseptic practices in manufacturing facilities and advice on best practice to ensure the approach taken is in line with industry best practice and meets regulatory requirements.
- To provide specialist microbiology training to relevant personnel involved in cGMP activities including QC/QA, manufacturing, and external personnel as necessary.
- To be responsible for the microbiological competency checks of QC/QA Staff, and assessment before signing off Training Records.
- Act as a Subject Matter Expert (SME) during MHRA Regulatory Inspections and NHS Quality Audits.
3. Resource Management - To manage the procurement and stock control of microbiological media, reagents and consumables and ensure there is adequate supply of relevant media, proper stock rotation to assure optimal stock control and maintenance.
- To manage sub-contract companies for outsourced microbiological testing. To generate needed documentation to the contract laboratory. When necessary to dispatch samples for specific tests.
4. Research and Development (including Clinical Trials) - To provide support to the development, formulation and validation of new products in response to clinical trial and clinical need and risk management in accordance with client and trust objectives.
- To assist in the review of clinical trial documentation and assess whether the production of the Investigational medicinal product (IMP) comes under the MA (IMP) license. To ensure that all IMP production (licensed and unlicensed) follows the principle of GMP and GCP.
- To assist in the review and authorisation of IMP production documentation with microbiological testing requirement to ensure the preparation of the IMP complies with all regulatory requirements.
- To attend site visits by sponsors, clinical research organizations and their representatives to ensure that all pharmacy requirements for the undertaking of IMP production are available
- To lead in the response to audit deficiencies in a timely manner
- To assist in the critical assessment of current manufacturing methods with a view to improving the quality and efficiency of the manufacturing process.
- To undertake stability studies where required in line with current ICH guidelines or equivalent.
- To coordinate a rolling programme to investigate the validation and possible extension of current expiry dates attributed to manufactured batches.
- 5. CLINICAL SERVICES
- To assist in the provision of expert pharmaceutical QC/QA advice on the use of all the trusts manufactured products
- To assess the suitability of unlicensed medicines purchased by the trust and release for use as appropriate
- To assist in responding to MHRA drug alerts and coordinate retrieval, quarantine, and replacement of stock
- To assist in the temperature monitoring and mapping of relevant drug storage areas and communication of results and excursions to all relevant areas of the trust
6. PROFESSIONAL RESPONSIBILITIES
To remain on the relevant Professional register.
- To undertake GCP and GMP training as required.
- To maintain 100% MAST record.
- To act as a role model to all other Pharmacy staff.
- To always behave in a manner that is professional, positive and polite.
- To be accountable for own professional actions.
- To be responsible for ensuring that (s)he remains aware of current developments in pharmacy, human resources and employment law
- To be responsible for his/her own professional development and participate in own Performance and Development planning.
- To complete CPD where applicable.
- Business and Intellectual Property
- To ensure all research and development relating to new product testing is fully costed with respect to microbiological requirements.
- To help identify and manage issues of intellectual property
- Other Duties
To undertake other duties as requested by the Head of Pharmaceutical Quality Services and the Group Chief Pharmacist.
To contribute to pharmacy weekend, late duty and bank holidays rotas as required.
To work across all sites and other NHS production units when required.
GENERAL RESPONSIBILITIES
Infection Control
Infection control is everyones responsibility. All staff, both clinical and non clinical, are required to adhere to the Trusts Infection Prevention and Control policies and procedures and the Health Act (2006) Code of Practice for the prevention and control healthcare associated infections and make every effort to maintain high standards of infection control at all times thereby reducing the risk of Healthcare Associated infections.
It is the duty of every member of staff to take personal responsibility for the prevention and control of infection, as laid down in the Trusts polices and procedures which reflect the statutory requirements of the Hygiene Code.
- To work in close collaboration with the Infection Control Team.
- To ensure that monitoring of clinical practice is undertaken at the agreed frequency.
- To ensure that the ward environments are cleaned and maintained to the highest standards; ensuring that shortfalls are rectified, or escalate as necessary.
- To ensure that all relevant monitoring data and issues are provided to the Directorates Governance structures.
- To ensure that all staff are released to attend infection control-related educational sessions and staff with specialist roles, e.g. link practitioners, are released to undertake their duties.
Health and Safety at Work
The post holder is required to:
- Take reasonable care for the health and safety of himself/herself and other persons who may be affected by their actions or omissions at work.
- Co-operate with the employer in ensuring that all statutory and other requirements are complied with.
- To improve understanding of hazards specific to Aseptic service & COSHH materials and highlight ways of reducing risks to staff.
Location of work
The appointment is specifically not designated as being permanently in one place. The Trust reserves the right to require staff to work at such other places or locations as it considers reasonable and necessary on a temporary or more permanent basis
Pharmacy Services
The Pharmacy Services of the Royal Free London are constantly evolving to best meet the needs of patients and our healthcare colleagues and partners and this may lead to providing a full and comprehensive Pharmaceutical support over 7 days a week.
Person Specification
Education & professional Qualifications
Essential
- Bachelor of science degree in microbiology or relevant Science degree
- Full membership of a relevant Professional Body
- Mandatory CPD to maintain fitness to practice
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Experience
Essential
- Significant experience in Quality Assurance/control microbiology in hospital or industrial environment
- Skilled in microbiological testing techniques to include Total viable counts, Steriltyt testing, LAL Endottoxin testing, Microbial environmental montoring, Pharmaceutical water and non-clinical microbiological testing.
- Experience of training and supervising staff
- Practical knowledge of and commitment to the principles of cGMP, GLP, QA and all current legislation and regulations and ability to apply this knowledge to develop and run Quality Services
- Demonstrated knowledge of principals and practices of formulation, stability, of products and manufacturing processes.
- Knowledge of COSHH and health and safety at work
- Advanced knowledge of microbiological techniques to include preparation of culture media, positive control tests on prepared micro media. Trend analysisand generating appropriate monitoring reports
Desirable
- Previous leadership role in a pharmaceutical manufacturing facility that include sterile product manufacture.
- Knowledge and / or ability to work with high precision laboratory equipment e.g UV, IR and HPLC methods and in the development and validation of analytical methods
- Previous experience in validation of pharmaceutical manufacturing processes, equipment and products
- Demonstrated experience & ability to supervise and undertake a range of technical projects
- Practical knowledge on the manufacture and analysis of pharmaceutical products and ability to identify and manage associated risks
- Demonstrated knowledge of Medical Piped Gas Testing
Person Specification
Education & professional Qualifications
Essential
- Bachelor of science degree in microbiology or relevant Science degree
- Full membership of a relevant Professional Body
- Mandatory CPD to maintain fitness to practice
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Experience
Essential
- Significant experience in Quality Assurance/control microbiology in hospital or industrial environment
- Skilled in microbiological testing techniques to include Total viable counts, Steriltyt testing, LAL Endottoxin testing, Microbial environmental montoring, Pharmaceutical water and non-clinical microbiological testing.
- Experience of training and supervising staff
- Practical knowledge of and commitment to the principles of cGMP, GLP, QA and all current legislation and regulations and ability to apply this knowledge to develop and run Quality Services
- Demonstrated knowledge of principals and practices of formulation, stability, of products and manufacturing processes.
- Knowledge of COSHH and health and safety at work
- Advanced knowledge of microbiological techniques to include preparation of culture media, positive control tests on prepared micro media. Trend analysisand generating appropriate monitoring reports
Desirable
- Previous leadership role in a pharmaceutical manufacturing facility that include sterile product manufacture.
- Knowledge and / or ability to work with high precision laboratory equipment e.g UV, IR and HPLC methods and in the development and validation of analytical methods
- Previous experience in validation of pharmaceutical manufacturing processes, equipment and products
- Demonstrated experience & ability to supervise and undertake a range of technical projects
- Practical knowledge on the manufacture and analysis of pharmaceutical products and ability to identify and manage associated risks
- Demonstrated knowledge of Medical Piped Gas Testing
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
