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GMP Facility Officer

Employer
KINGS COLLEGE LONDON
Location
London (Central), London (Greater)
Salary
£37,332 – £42,099 per annum, including London Weighting Allowance
Closing date
7 Mar 2024

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Job Details

Job description

The Cell and Gene Therapy, King's (CGT-K) group manufactures a variety of Advanced Therapy Investigational Medicinal Products (ATIMPs) and starting materials, in state-of-the-art Good Manufacturing Practice (GMP) facilities for the treatment of cancer and rare diseases. This post supports the translation of cutting-edge medical research into clinical application. The position is based in a team with an excellent track record in both basic and translational research.

The GMP Facility Officer will work as part of the Facilities Team to ensure the CGT-K GMP facilities are fit for purpose and maintained in a manner to support the ATIMP and viral vector manufacturing activities. The role holder will also work closely with the Quality Assurance (QA) team to ensure the CGT-K facilities comply with the requirements of the Pharmaceutical Quality System (PQS) and with the Production team to ensure the manufacturing schedule can be maintained.

Tasks undertaken will include but not be limited to: 

  • Organisation and booking of engineers/service provider to execute routine equipment and facility maintenance, service and annual requalification visits and emergency repair visits.  
  • Liaising with KCL estates to ensure engineer permits to work are issued.  
  • Ensure the planned preventive maintenance is carried out as per the schedule and the tracking system is kept up to date. 
  • Carryout in-house equipment calibrations and IQ/OQ  
  • Participate in writing change controls for facility and equipment and undertaking change control activities. 
  • Assist the Facility Manager in maintaining equipment records in accordance with the PQS. 
  • Undertaking daily logging of equipment and facility temperatures and acknowledgement of facility / equipment alarms on the Facility Monitoring System.  
  • Take part in the investigation of facility alarms, out of specification events and quality exceptions and implement corrective and preventive actions in conjunction with the Quality Assurance team.  
  • Draft quality system documentation including but not limited to Standard Operating Procedures and equipment validation documents. 
  • Participate in internal audits.

The GMP Facility Officer will be responsible to the GMP Facility Manager.

This would be an excellent position for someone who wishes to develop a career within the operational management and maintenance of GMP cleanroom facilities.

This post will be offered on an indefinite contract.

This is a full-time post - 100% full time equivalent.

Key responsibilities

  • Day to day responsibility for ensuring equipment and facilities are serviced as per the planned preventative maintenance schedule, including booking engineer routine equipment & facility maintenance, requalification visits and emergency repair visits in line with applicable GMP and HTA requirements. 
  • Day to day responsibility for liaising with KCL estates to ensure engineer’s/ service provider’s permits to work are issued and that engineer/service provider inductions are completed. 
  • Accompany the engineers into the cleanrooms/controlled areas, including cleaning in of the engineer’s equipment. 
  • Day to day responsibility for daily logging of equipment and facility temperatures.  
  • Day to day responsibility for acknowledgement of facility / equipment alarms on the Facility Monitoring System (FMS) as per the FMS standard operating procedure.  
  • Carry out in-house equipment calibrations or assist the Production Team as applicable. 
  • Carryout in-house IQ/OQ of equipment.  
  • Carryout in-house annual requalification of equipment. 
  • Day to day responsibility for notifying staff of out of use equipment, labelling equipment and bring the equipment back in to use as per the standard operating procedure. 
  • Be responsible for data backup in conjunction with QA. 
  • Ensure equipment and facility records are maintained in accordance with the PQS. 
  • Assist QA with the weekly facility authorisation. 
  • Take part in the investigation of facility and equipment alarms, out of specification events and quality exceptions and implement corrective and preventive actions in conjunction with the Facility Manager and Quality Assurance team.  
  • Participate in internal audits.  
  • Participate in writing change controls for facility and equipment and undertaking change control activities. 
  • Draft quality system documentation including but not limited to Standard Operating Procedures and equipment validation documents. Perform equipment validation and prepare summary reports. 
  • Assistance in routine facility housekeeping activities including: 
  • Weekly checks of the facilities and support areas to ensure they are maintained in a fit for purpose state. 
  • Managing of laundry including receipt and packing for sending. 
  • Waste management. 

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.

Skills, knowledge, and experience

Essential criteria

  1. Educated to degree level or equivalent 
  2. Experience in maintaining databases, tracking spreadsheets or inventories  
  3. Experience in liaising with external and internal suppliers, contractors, service providers or stakeholders 
  4. Experience of working in or maintaining a cleanroom environment 
  5. Experience in equipment IQ/OQ, routine maintenance and / or calibration 
  6. Experience in working to SOPs or written formal instructions 
  7. Working knowledge of formal quality systems for change control and deviations 
  8. Excellent organisational skills with demonstrable ability to balance competing demands and priorities 
  9. Demonstratable experience of problem solving 
  10. Experience of writing health and safety risk assessments and COSSH

Desirable criteria

  1. Experience of all aspects of QA/QC in relation to production of ATIMPs in particular Change Control, Document Control, Process Validation, Equipment Management CAPA, Quality Risk Management 
  2. Working knowledge of a facility monitoring system

Further information

This post is subject to Disclosure and Barring Service and Occupational Health clearance.

Company

King's College London is one of the top 20 universities in the world and among the oldest in England. King's has more than 27,600 students (of whom nearly 10,500 are graduate students) from some 150 countries worldwide, and some 6,800 staff.

King's has an outstanding reputation for world-class teaching and cutting-edge research. In the 2014 Research Excellence Framework (REF) King’s was ranked 6th nationally in the ‘power’ ranking, which takes into account both the quality and quantity of research activity, and 7th for quality according to Times Higher Education rankings. Eighty-four per cent of research at King’s was deemed ‘world-leading’ or ‘internationally excellent’ (3* and 4*). The university is in the top seven UK universities for research earnings and has an overall annual income of more than £684 million.

King's has a particularly distinguished reputation in the humanities, law, the sciences (including a wide range of health areas such as psychiatry, medicine, nursing and dentistry) and social sciences including international affairs. It has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA and research that led to the development of radio, television, mobile phones and radar.

King's College London and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts are part of King's Health Partners. King's Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world's leading research-led universities and three of London's most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. For more information, visit: www.kingshealthpartners.org.

King’s £600 million campaign, World questions|KING’s answers, has delivered huge global impact in areas where King’s has particular expertise. Philanthropic support has funded new research to save young lives at Evelina London Children’s Hospital; established the King’s Dickson Poon School of Law as a worldwide leader in transnational law; built a new Cancer Centre at Guy’s Hospital; allowed unique collaboration between leading neuroscientists to fast-track new treatments for Alzheimer’s, Parkinson’s, motor neurone disease, depression and schizophrenia at the new Maurice Wohl Clinical Neuroscience Institute; created the Cicely Saunders Institute: the first academic institution in the world dedicated to palliative care, and supported the King’s Sierra Leone Partnership in the Ebola crisis. Donations provide over 300 of the most promising students with scholarships and bursaries each year. More information about the campaign is available at www.kcl.ac.uk/kingsanswers.

Company info
Mini-site
KINGS COLLEGE LONDON
Telephone
+(44)02078365454
Location
STRAND
LONDON
WC2R 2LS
United Kingdom

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