Senior QC Microbiologist Lead

2 days ago


Hatfield, Hertfordshire, United Kingdom CK Group Full time
Job Description

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.
Your Background

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.
Salary

The estimated annual salary for this position is around £65,000 - £75,000, depending on experience.



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