Senior QC Microbiologist

CK Group are recruiting for a Senior QC Microbiologist, to join a well-established and successful global pharmaceutical company, based in Hatfield, Hertfordshire, on a fixed term contract basis for 12 months.

Role:

This job is responsible for providing technical expertise on all microbiological topics and the ability to test all materials/facility for microbiological contamination according to agreed specifications and procedures and within agreed lead times as required.

Key duties will include:

• As subject matter expert, 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.

• 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.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 109 116 in all correspondence.