Quality Assurance Microbiologist

3 weeks ago


Hatfield, United Kingdom CK Group- Science, Clinical and Technical Full time
Job Overview
Career Opportunity with CK Group - Science, Clinical and Technical

CK Group is a leading science, clinical and technical recruitment agency in the UK. We are currently recruiting for a Senior QC Microbiologist to join one of our prestigious clients, a well-established global pharmaceutical company based in Hatfield, Hertfordshire. This is a fixed term contract position for 12 months.

The ideal candidate will have experience working in a senior role within a QC Microbiology laboratory, excellent technical knowledge of Microbiological testing techniques, and a demonstrated understanding of GMP Guidelines and Regulations. The successful applicant will be responsible for providing technical expertise on all microbiological topics and ensuring compliance with regulatory requirements. They will also provide training and coaching to team members to strengthen their technical knowledge. Salary: £55,000 - £65,000 per annum.

Key Responsibilities
- Review, evaluate and implement changes to the QC microbiology department in line with current regulatory requirements.
- Provide training and coaching to team members to strengthen their technical knowledge.
- Test all materials requiring microbiological testing according to agreed specifications and procedures and take and test Environmental Monitoring samples according to the monitoring schedule.
- Qualify (URS, IQ, OQ, PQ) all microbiological laboratory equipment and maintain and calibrate all microbiological laboratory equipment according to approved procedures.
- Maintain all microbiological laboratory Quality Systems and Quality Management Systems in compliance according to approved procedures.
- Write SOPs associated with microbiological support.
- Support the internal and external audit process and audit schedules as appropriate and support the preparation and hosting of competent authority inspections.
- Raise and support the Deviations, Investigations and associated CAPA's and support the implementation of change control activities.
- Support analytical method transfers and in particular any microbiological QC aspects of these.

Your Background
- Educated to degree level or above in Microbiology or a related field.
- Experience in a senior role within a QC Microbiology laboratory.
- Excellent technical knowledge of Microbiological testing techniques e.g. water testing, microbial limit testing and identification techniques.
- Demonstrated Knowledge, understanding and application of GMP Guidelines and Regulations.
- Knowledge of Quality Control, Quality Assurance and Quality Systems and a basic understanding of the manufacture and packaging of pharmaceutical products.

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