Job summary
Due to promotion, we are looking for an enthusiastic, motivated individual with an interest in pharmaceutical microbiology. Ideally the candidate will have experience in undertaking monitoring activities or working in the cleanroom environment and is familiar with performing settle and contact plating, completing swabs along with air and particulate sampling.
The candidate will not only undertake monitoring activities but read plates, liaise with contract laboratories to identify organisms recovered and report results back to our manufacturing units which are critical to ensure environmental control is maintained.
This is an ideal opportunity for a recent graduate in a biology / microbiology / biomedical sciences field or an aseptic / production operator who has previously successfully undertaking monitoring activities in a cleanroom / laboratory environment.
Training on gowning procedures and sampling techniques will be provided.
Note: this post operates across both Guys (London Bridge) and St Thomas' (Waterloo) sites
If you are looking for a new challenge then this could be the opportunity for you.
Main duties of the job
To undertake the physical and environmental monitoring of aseptic, production, radiopharmacy and other trust manufacturing units. Supervision of media incubation and reading/recording of results of microbiological recoveries and accurately imputing data onto Quality Management Systems in accordance with GMP and current departmental procedures.
About us
Department Information
The Pharmacy Quality Assurance department at Guy's and St Thomas NHS Foundation Trust is an independent department within Pharmacy which provides support and guidance to clinical pharmacists and in-patient pharmacy dispensaries at Guys and St Thomas' Hospital plus alongside the on-site Quality Control department provide a full Quality Assurance manufacturing and product release service to aseptic, sterile and non-sterile manufacturing. There is a new classical manufacturing facility on the Guy's site, a new Parenteral Nutrition Unit on the St Thomas site and a new chemotherapy pharmacy in the Guy's Cancer Centre
The manufacturing units undertake a wide range of manufacturing and dispensed activities to provide medicines to meet the special clinical needs of patients which are not commercially available. Each unit has a full complement of Pharmacists, Technicians and Assistants and prepare a wide range of products.
Job description
Job responsibilities
Pharmacy Quality Assurance Micro-team SATO
- To carry out routine physical and microbiological environmental monitoring of pharmaceutical production areas following Standard Operating Procedures and schedules.
- To use environmental monitoring and other QA equipment correctly by following the procedures for use, cleaning and monitoring of such equipment.
- To ensure that all required documentation is filled in correctly, processed and filed in the correct manner according to GMP principles.
- To maintain and update accurate record logs of environmental monitoring undertaken and subsequent results.
- To assist in the arrangements for QA equipment calibrations.
- To accept delivery of materials for the Pharmacy QA micro-team.
- To book in raw materials and containers on receipt from external suppliers according to Standard Operating Procedures.
- To assist in the stock control of media used in the microbiological monitoring service.
- To actively assist senior staff in the maintenance of the Quality Management System.
- To contribute to the development of GMP documentation such as standard operating procedures and worksheets.
- To contact Manufacturers and Suppliers to obtain appropriate Certificate of Analysis or Certificates of Conformity for received raw materials and containers.
- To ensure that working procedures at all times conform with standards of Good Laboratory Practice, The Health and Safety at Work Act, Control of Substances Hazardous to Health Regulations and other relevant legal and professional directives.
General:
- To undertake other duties as required in order to maintain the safe, efficient and effective provision of Pharmaceutical services.
- To contact appropriate supervisor for assistance as required when undertaking the activities of this job description.
- To attend courses and undertake training to develop expertise in appropriate skills, where training needs are identified.
Job description
Job responsibilities
Pharmacy Quality Assurance Micro-team SATO
- To carry out routine physical and microbiological environmental monitoring of pharmaceutical production areas following Standard Operating Procedures and schedules.
- To use environmental monitoring and other QA equipment correctly by following the procedures for use, cleaning and monitoring of such equipment.
- To ensure that all required documentation is filled in correctly, processed and filed in the correct manner according to GMP principles.
- To maintain and update accurate record logs of environmental monitoring undertaken and subsequent results.
- To assist in the arrangements for QA equipment calibrations.
- To accept delivery of materials for the Pharmacy QA micro-team.
- To book in raw materials and containers on receipt from external suppliers according to Standard Operating Procedures.
- To assist in the stock control of media used in the microbiological monitoring service.
- To actively assist senior staff in the maintenance of the Quality Management System.
- To contribute to the development of GMP documentation such as standard operating procedures and worksheets.
- To contact Manufacturers and Suppliers to obtain appropriate Certificate of Analysis or Certificates of Conformity for received raw materials and containers.
- To ensure that working procedures at all times conform with standards of Good Laboratory Practice, The Health and Safety at Work Act, Control of Substances Hazardous to Health Regulations and other relevant legal and professional directives.
General:
- To undertake other duties as required in order to maintain the safe, efficient and effective provision of Pharmaceutical services.
- To contact appropriate supervisor for assistance as required when undertaking the activities of this job description.
- To attend courses and undertake training to develop expertise in appropriate skills, where training needs are identified.
Person Specification
Education/Knowledge
Essential
- Numerate and literate
- Computer literate (Microsoft office applications)
Desirable
- GCSE (or equivalent) Grade C or above in Maths and English.
- NVQ Level 2 in Pharmacy Services or equivalent
Experience
Essential
- Demonstrated ability to work accurately to set procedures.
- Demonstrated ability to work as part of a team and under own initiative.
- Demonstrated ability to prioritise and organise routine daily tasks using own initiative.
- Demonstrated ability to communicate routine information effectively using clear written and spoken English.
Desirable
- Demonstrated ability to undertake tasks within an aseptic preparation area.
- Demonstrated practical understanding of the principles of GMP and QA.
Skills
Essential
- Ability to work within a team and under own initiative
- Ability to work unsupervised after suitable training.
- Able to work under pressure and prioritize workload
Desirable
- Willing to ensure continuing education and professional development
Person Specification
Education/Knowledge
Essential
- Numerate and literate
- Computer literate (Microsoft office applications)
Desirable
- GCSE (or equivalent) Grade C or above in Maths and English.
- NVQ Level 2 in Pharmacy Services or equivalent
Experience
Essential
- Demonstrated ability to work accurately to set procedures.
- Demonstrated ability to work as part of a team and under own initiative.
- Demonstrated ability to prioritise and organise routine daily tasks using own initiative.
- Demonstrated ability to communicate routine information effectively using clear written and spoken English.
Desirable
- Demonstrated ability to undertake tasks within an aseptic preparation area.
- Demonstrated practical understanding of the principles of GMP and QA.
Skills
Essential
- Ability to work within a team and under own initiative
- Ability to work unsupervised after suitable training.
- Able to work under pressure and prioritize workload
Desirable
- Willing to ensure continuing education and professional development
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.
