Senior Microbiologist

Senior Microbiologist

Luton, Bedfordshire

Company Profile

Bristol Laboratories is a fast-growing pharmaceutical company engaged in the development, manufacture, marketing, and distribution of generic medicines in the UK and Europe. We work to offer a wide range of high-quality medicines to the health sector in the UK, which optimizes cost efficiency and ensures reliable supply.

About the job and Key Responsibilities:

• Perform water sampling and testing.
• Perform Microbiological analysis and documentation of raw materials, in-process samples, bulk samples, finished products, stability samples and Growth promotion Test (GPT), respectively.
• Receipt and testing of media.
• Perform First stage of identification of microorganisms (Gram stain and APIs).
• Receive, store, and print appropriate Certificate of Analysis (COA) for Microbiology consumables.
• Check the calibration status of Microbiological instruments.
• Perform Compressed Air Monitoring.
• Perform Environmental Monitoring.
• Be involved in the preparation and approval of SOPs, methods, and various reports.
• Work under the guidance of current Good Manufacturing Practices (cGMP).
• Strict adherence to health and safety requirements.
• Perform and monitor Microbiological method validations.
• Maintain and manage microbial pure cultures as per procedure.
• Plan and organize daily analysis schedules based on the samples from the production and warehouse departments.
• Coordination with production and QA department for analysis of samples during validation studies.
• Periodic procurement of Microbiology cultures, data acquisition from incubator, review and monitoring of all usage logbooks, daily calibration records and regular updates.
• Be involved in the handling and management of deviations, change controls, CAPAs, Risk assessments and other GMP compliances within the Microbiology laboratory.
• Be involved in the handling and management of OOS/OOT and LIR
• Planning and execution of the preparation and reviewing of SOPs within the Micro department.
• Preparation and review of trend charts for Environmental Monitoring.
• Maintenance and execution of GQCLP activity in the laboratory.
• Reviewing, performing, and documenting Microbial test results.
• Coordination, facilitation, and participation in Environmental Monitoring studies and respective documentation.
• Coordination, facilitation, and performing the required tests/qualifications on input materials within the microbiology department (media, pure culture; chemicals, glassware; monitoring, and measuring devices).
• Ensure cleanliness and hygiene practices within the microbiological testing lab.
• Coordination, facilitation, and participation in failure investigations.
• Ensure maintenance and management of analytical instrument including the qualification, calibration, and periodic maintenance.
• Perform instrumental analysis as per approved specification/test methods.
• Facilitate/participate in self-inspections, internal quality audits, customer audits and regulatory inspections.
• Perform any other responsibilities assigned by Management Supporting Activities.

This is a fantastic development opportunity for someone seeking the next step in their management career in a high-profile environment.