The successful candidate will ensure microbiological testing is completed accurately and within required timelines, while maintaining compliance with cGMP, pharmacopoeial requirements and applicable Marketing Authorisation conditions.
Key responsibilities:
* Organise the routine activities of the microbiology laboratory to meet operational requirements.
* Perform microbiological testing and accurately record, analyse and interpret results.
* Ensure data integrity is maintained across all microbiological activities.
* Write protocols and reports for microbiological testing when required.
* Conduct OOS and out-of-trend investigations, including root cause analysis.
* Maintain microbiological procedures in line with pharmacopoeial and Marketing Authorisation requirements.
* Support the QC Manager in developing and implementing robust laboratory practices.
* Provide quality metrics and reports relating to microbiological laboratory activities.
* Maintain laboratory equipment and ensure the laboratory remains adequately stocked and inspection-ready.
* Establish and maintain relevant laboratory KPIs.
* Participate in self-inspections and regulatory inspections.
* Keep up to date with technical developments relevant to microbiological testing.
* Follow all company GMP, SOP, health and safety, and quality procedures.
Requirements:
* A degree in Microbiology, Biology, Pharmacy or another relevant life science subject.
* Previous microbiology testing experience within a pharmaceutical or regulated environment.
* Good knowledge of GMP, data integrity, SOPs and MHRA requirements.
* Knowledge of pharmacopoeial and Marketing Authorisation requirements for microbiological testing.
* Experience with OOS investigations, out-of-trend investigations and root cause analysis would be beneficial.
* Previous involvement in self-inspections or regulatory inspections would be advantageous.
* Strong attention to detail and a commitment to data accuracy.
* Excellent organisational, communication and time-management skills.
* A reliable, positive and collaborative approach to work
Salary description
£32000.00 - £34000.00 per year