Cranleigh
Location
Berkshire | United Kingdom
Job description
Our client is a leading biotechnology company specialising in the development and manufacturing of innovative biological products. The company is seeking a dedicated and detail-oriented QC Laboratory Supervisor to join their dynamic team in Newbury. The state-of-the-art laboratory facility is equipped with cutting-edge technologies and serves as the hub for research and development activities. They are committed to making a positive impact on health and the environment through our scientific advancements.
The Role
Supervising the Quality Control team.
o Ensuring day-to-day running of QC Microbiology laboratory
o Line management responsibility for QC Analysts including training, leadership and recruitment using People Cloud a bespoke HR toolkit.
o Training new members of staff in microbiology-related activities and ensuring that the required initial and continuing training of Lab personnel is carried out and adapted according to their needs and areas of interest.
Delivering workflow to support the production schedules to meet customer requirement dates through:
o Execution of sampling & protocols required as part of sterile process assurance.
o Performing routine QC testing to support batch release, validation, and method development studies.
o Performing in-house batch release testing on vaccines (including weekend cover) and managing microbiological testing for environmental monitoring and other duties to support the GMP facility.
o Overseeing the lab's input for the daily PDR (Plan, Do, Review) Meeting.
Maintaining Quality standards through:
o Continuous improvement of the sterile process assurance.
o Presenting technical microbiological issues and results to internal and external audits
o Ensuring the QC lab performs testing and release of Raw Materials, packaging materials, intermediate, bulk and finished products.
o Keeping procedural documents (SOPs) and policies on Environmental Monitoring relevant and up to date with regulation guidelines.
o Responsible for microbiological test implementation: method development, validation, and documentation.
o Ensure that the monitoring procedures are performed on time for the trending of microbiological data for all required sampling, ensuring data integrity.
o Investigations of out of specifications/ atypical results obtained from microbiological
testing.
o Lead microbiology compliance in QC related tasks
o Documenting microbiological records to ensure compliance with cGMP.
o Regularly reporting of results and summaries of own work to line manager.
Ensure compliance with required Health and Safety standards and ensure that there is a representative of the Lab on the Health and Safety committee.
Contribute to the development of the Company's operational process by:
o Maintaining effective working relationships within and between all team members.
o Providing laboratory KPI information, assisting your line manager in reporting performance.
o Responsible for ensuring the maintenance, qualification, and validation of microbiology laboratory equipment and supporting new equipment installation as required.
Experience Required
A BSc/MSc Degree or equivalent in a relevant field
Good experience of working in microbiology, specifically supporting sterility testing and environmental monitoring activities in pharmaceutical environment
Good understanding of GMP and ability to front external audits.
Good Microsoft Office skills
Excellent Communication, leadership and Team working skills.
Excellent accuracy and attention to detail.
Experience in QC chemistry would be advantageous but not essential.
The ability to manage multiple projects and tasks in an evolving environment.
Technical knowledge of emergency (bespoke} vaccine products.
Salary £30k - £35k
Job Ref: 7938
Job tags
Salary
£30k - £35k per annum
