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Baxter
,
London, Greater London
Microbiology Supervisor
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Job Type: Full-time |
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Overview
Summary As part of the Quality team the Microbiology Supervisor will work closely with the Quality Assurance Manager and the Sterility Assurance group for Baxter to maintain an understanding of the microbiological risks to the Aseptic Manufacturing process, how to mitigate and control these risks and to implement studies to support and enable best practice in contamination control and aseptic processing. The post holder must be familiar with the regulatory requirements specific to the micro laboratory. Essential Duties and Responsibilities Make recommendations for new equipment and methodology Ensures all reagents and supplies are available when needed. Liaise with external supplier regarding laboratory equipment and consumables Requesting quotes and placing orders Prepare monthly quality reports regarding EM Organise proficiency test (internal and external) Maintain laboratory microorganism library (ATCC strains and in-house isolates) Perform and train QC staff in aseptic technique, micro identification tests and media QC Evaluates existing systems and processes and develops corrective action plans for service/quality trends identified Initiates changes and monitors for improvement Organise QC testing in the laboratory and schedule validation testing in production Ensures that QC laboratory proactively respond to production need Track validations exercise in the production Reviewing and approving test reports Issuing Green Light for production To provide organisational expertise in Microbiology To provide the following training to the production staff: Basic Microbiology, Cross contamination, Cleanroom behavior and cleaning and Disinfection practice To lead site compliance and remedial activities in microbiologically related areas To ensure suitable risk based decision making occurs relevant to EM data and presence of certain organisms To ensure best practice is followed to reduce clean room contamination To supervise routine Environmental Monitoring duties within the cleanrooms and manufacturing areas. To prepare technical documentation within the department. To carry out and manage projects in the department as required. To develop and validate relevant cleanroom and manufacturing procedures within the department as and when required. To review microbiological and cleanroom and manufacturing area data for accuracy, completeness and compliance with documented procedures. To communicate effectively and proactively with others on site and participating with departmental and site wide problem solving as required. To ensure that all work carried out and documentation complies with departmental procedures and GMP Quality Assurance Participate in internal and external audits as defined by the relevant schedules or as required Own and support Change Controls (where appropriate to job role) Provide support for validation activities (where appropriate to job role) Support with the administration of the Materials Management/Vendor (where appropriate to job role) Assurance process Technical Support Microbiology specialist and technical assessor Process Improvement support Project and new initiatives support Qualifications Degree in Science - Preferably Microbiology or Biology Job Description