MicrobiologistHolmes Chapel 12 monthsGBP20 per hour via umbrellaThis role provides testing, reporting and investigation laboratory activities to enable compliant, on time delivery of product to market. This is a key position within a QC team ensuring that the exacting standards of GMP, Site procedures, HSE and LEAN are delivered at all times.
- Quality Microbiologist conducts testing, reporting of results and investigations within the microbiology laboratory (product testing, facilities/utilities and microbiology laboratory support areas).
- The Quality Microbiologist is charged with performing their work in a safe and effective manner in compliance with cGMP, Biosafety and Regulatory requirements.
- The function of this position is to perform Microbiological sampling and testing following approved methodology, to assure that the potency, purity, safety and stability of our products, components and facilities/utilities are in compliance with approved specifications.
- Additionally, this position evaluates Microbiological methods, reviews test results, highlights problems related to technical and equipment issues and works closely with the Senior Quality Microbiologist/Microbiology Quality Leader to aid resolution of any issues. All staff may be required to perform additional duties as agreed by the supervisor.
- Conducts testing of QC samples for the specific laboratory area and manage own workload
- Analyse data using standard procedures
- Contribute to quality key performance indicators and deliver, measure/trend data to team.
- Challenge and seek improvements in ways of working/processes
- Perform testing according to prioritisation and contribute to any improvements
- Provide Microbiological/lab support for Team Leader in internal, Global regulatory inspections and customer audits when required.
- May have involvement in the training of other members within the team, particularly in the case of team members who are new and inexperienced.
- Has regular involvement with investigations (i.e. Events/ILI/FSI), working within their local area to aid in problem solving, identification of root cause and meaningful CAPA.
- Recognises opportunities for change and has a proven ability to drive change in the local area.
- May be required to support in the review of analytical methods and compendia to ensure compliance for both GMP and HSE considerations
QualificationsA science degree / HND/ NVQ 4 or equivalent with at least 1 years working experience in a GMP environment SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS
- Good technical knowledge and expertise of quality control principles and systems in a GMP environment.
- Computer-literate with experience in the use of Laboratory (LIMS, Data capture) systems as well as MS Word, Excel and PowerPoint
- Demonstrated ability to actively participate in projects and investigation
- Knowledge and understanding of global pharmaceutical regulations and guidelines.
- Demonstrates competence and clarity in both written and oral communication e.g. presentations at team meetings, ability to write ILIs and demonstrates understanding to execute FSIs as well as non-complex technical and investigational reports, communication at team meeting
- Good interpersonal skills with an ability to communicate procedures and concepts within the team and on occasions to the department. Ability to train instructional techniques
- Self-motivated with ability to plan and manage own workload with some supervision during the working day.
- Challenges and questions locally and across team ways of working to seek improved processes and performance
- Takes responsibility for supporting change, is prepared to take or support action, and/or escalate to ensure implementation of appropriate actions
- Ability to respond to auditor questions and describing local systems on external audit tours with positive outcomes
- The individual should have good knowledge and understanding of the principles and concepts of compliance management and GMP/GLP
- The individual should have a good understanding of analytical chemistry or microbiology, laboratory instrumentation and/or related information systems.
- The individual should have a basic understanding of the industry and be responsive to of regulatory changes, new technologies, Pharmacopoeial requirements and their impact on the function.
- An understanding of own quality assurance function, as well as a basic understanding of other functions and how they contribute to achieving the objectives of the business.
- The individual has some understanding of business functions and supports reacting to issues on how QC performance impacts functional customer service.