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