Job Description
CK Group are recruiting for a Senior QC Microbiologist with 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:
o Educated to degree level or above in Microbiology or a related field.
o Experience in a senior role within a QC Microbiology laboratory.
o Excellent technical knowledge of Microbiological testing techniques e.g. water testing, microbial limit testing and identification techniques
o Demonstrated Knowledge, understanding and application of GMP Guidelines and Regulations
o 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. For more information or to apply for this position please contact Mary Bolt on 01246 457729 or email mbolt@ckgroup.co.uk. Please quote job reference 148 588 in all correspondence.