Senior QC Microbiologist Lead
2 days ago
We are seeking a highly skilled Senior QC Microbiologist Lead to join our team at CK Group. Based in Hatfield, Hertfordshire, this is a fixed-term contract opportunity for 12 months.
This role provides technical expertise on all microbiological topics and ensures that materials/facility testing for microbiological contamination meets agreed specifications and procedures within lead times as required.
Main responsibilities include:
- Reviewing, evaluating, and implementing changes to the QC microbiology department in line with current regulatory requirements.
- Providing training and coaching to team members to strengthen their technical knowledge.
- Testing all materials requiring microbiological testing according to agreed specifications and procedures, taking and testing Environmental Monitoring samples according to the monitoring schedule.
- Qualifying (URS, IQ, OQ, PQ) all microbiological laboratory equipment and maintaining/calibrating all microbiological laboratory equipment according to approved procedures.
- Maintaining all microbiological laboratory Quality Systems and Quality Management Systems in compliance according to approved procedures.
- Writing SOPs associated with microbiological support.
- Supporting the internal and external audit process and audit schedules as appropriate, supporting the preparation and hosting of competent authority inspections.
- Raising and supporting Deviations, Investigations, and associated CAPA's, supporting the implementation of change control activities.
- Supporting analytical method transfers and particularly any microbiological QC aspects of these.
To be successful in this role, you will need:
- A degree level or above qualification 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.
The estimated annual salary for this position is around £65,000 - £75,000, depending on experience.
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