Job Description
The Company ITH Pharma specialises in the provision of Parenteral Nutrition, chemotherapy and CIVAS. Our team provides flexible services with batch and bespoke items for adults, paediatrics and neonates to both NHS and private hospitals.
The successful candidate will be joining a forward thinking organisation where sharing ideas and developing their people is how they have built their success.
We are looking for a Microbiologist to join our team within our busy Micro laboratory which services our clean rooms.
Main Duties
- To participate in the cleaning and preparation of monitoring equipment used in the aseptic unit in accordance with the principles of Good Manufacturing Practice. These principles are found in the ‘Orange Guide’ – Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017.
- To ensure all procedures associated with GMP activity are read initially and understood before the activity is commenced. Also that any updated procedures are read when issued.
- Operate to standards that satisfy the Medicines Inspectorate and other relevant authorities of which you will be informed.
- Ensure that all equipment and processes are validated and approved prior to being used or introduced.
- To monitor compliance with the requirements of GMP and report any deviations observed according to SOP.
- To ensure that the working environment is maintained in a tidy state. This includes all quality control areas and support areas such as the tea room. If maintenance or repair work is identified this must be reported to a supervisor.
- To ensure that the environment in which the products have been made conforms to the requirements of GMP e.g. Environmental and personnel microbiological monitoring, plate reading and follow up of out of spec results.
- Collect samples for microbiological testing of premises, staff and cleanrooms and that appropriate documentation is maintained.
- Microbiological analysis of environmental monitoring samples (routine and non routine) and other samples as required e.g. intermediate and finished products.
- Grow and identify microbe cultures including Gram staining and morphology.
- Retention of samples of isolates as required.
- To participate in quarterly monitoring of the entire production area.
- To ensure that all documentation associated with QC’s microbiological activities is recorded each time and is clearly written. All documents must be appropriately stored for easy retrieval.
- Accurate reporting of microbiological results, assisting in investigation and production of reports in accordance with SOP.
- Assisting in writing reports and reviews, e.g. VMP, change controls and risk assessments.
- To ensure policies are complied with in accordance with the Company Handbook. To ensure all accidents are reported and staff always comply with the requirements of the Health and Safety Executive.
- Adhere to COSHH regulations and Site Safety.
- To ensure all QC’s microbiological equipment is cleaned and maintained on a regular basis as defined by relevant SOPs.
- To ensure that all QC’s microbiological equipment is calibrated according to a maintenance schedule
- Enter data from microbiological environmental monitoring on the database in an accurate manner and review trends.
- Use of relevant computer software programmes.
- To ensure that any relevant out of spec results are reported, documented and investigated. This includes issuing MOOSE, providing additional data for risk assessment analysis, following up on ongoing MOOSEs and CAPA implementation.
- To ensure sufficient stock of media and consumables is available to provide an uninterrupted QC microbiological service.
- To ensure the evaluation/validation of new products/ processes.
The Person
You will need a degree within Microbiology (or associated experience ) and commercial experience within a microbiology laboratory post graduation.
You will need to have excellent analytical and communication skills and be able to work under pressure in a busy team.
Experience within an aseptic environment would be advantageous but is by no means essential.
Salary and Benefits In return, ITH Pharma offer competitive salaries with benefits including 22 days annual leave, PHI, shop styled self-service tea room, breakout areas, annual pharmacy allowance and contributory pension scheme; also the chance to progress your career within a leading organisation.
Job Types: Full-time, Permanent
Salary: £35,000.00-£40,000.00 per year
Schedule:
Ability to commute/relocate:
- London, NW10 7NZ: reliably commute or plan to relocate before starting work (preferred)
Work Location: One location