Walker Cole International
Microbiologist
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We are supporting an established pharmaceutical company in their search for a Microbiologist to join their Quality Control team. This is an excellent opportunity to take responsibility for the day-to-day running of a microbiology laboratory within a regulated pharmaceutical environment.
While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.
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.
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Requirements
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- 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.
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