A Day In The Life Of A Site Microbiologist
Lead the site in microbiology, ensuring that all appropriate microbiological standards and regulatory requirements are met.
Develop and maintain a culture in which all staff have full knowledge and understanding of the aspects of microbiology and hygiene appropriate to their role.
Provide technical expertise and leadership, consultation and collaboration to Operations for all aspects of sterile manufacture as appropriate.
Provide strong leadership in directing and supporting microbiological investigations, particularly critical investigations related to microbiological excursions.
Monitor developing regulatory and industry requirements and practices enabling Teva Runcorn to introduce new products and processes in an efficient and compliant manner and to manage the provision of compliant and cost effective microbiology service to the site.
Key Responsibilities:
Through a personal high profile presence ensure that microbiological and hygiene aspects of cGMP are understood by all and strictly enforced.
Monitor developing external technical and regulatory positions and ensure that appropriate actions are taken to maintain compliance.
Through a sound understanding of the science, ensure that all current regulatory requirements are met on site.
Implement monitor and maintain appropriate standards of control over process, personnel, environment and utilities to demonstrate compliance with all regulatory and Teva standards.
Analyse trends from microbiological data and collaborate with QC Microbiology in preparing periodic trend reports with appropriate recommendations for remedial/corrective actions where necessary and ensure this information is provided to site in a timely manner.
Provide expert review and oversight of all aspects of sterile manufacture at Teva Runcorn to ensure that the site operates in accordance with both Teva Corporate and Regulatory agency policies and guidelines.
Provide leadership and technical input to site on investigations related to microbiological excursions.
Maintain expertise in current pharmaceutical microbiology topics and regulations in order to provide accurate technical input on QC Microbiology and Operations inspection readiness as well as the most efficient and comprehensive methods for preventing microbial contamination of Teva Runcorn’s products.
Who We Are Looking For
Do you have?
Degree qualified in a Microbiology discipline
Significant experience of pharmaceutical microbiology; a portion of which should have been gained in a management role in the aseptic manufacture or testing of sterile products.
Advanced knowledge of the requirements for and the science behind a number of the following is expected…
Clean room design and environmental monitoring;
Advanced aseptic techniques using isolators or RABS;
Sterilization technologies especially steam;
Gamma irradiation and UV; rapid microbiological methods;
Cleaning and disinfection;
Microbial taxonomy and identification;
Water systems and training.
Evidence of continuing professional development of a microbiology function
Are you?
A confident communicator with the ability to persuade and influence all levels of colleagues, regulators and industry specialists.
Able to hold the highest standards of integrity, especially in decision making and the application of those standards.
If so – we would value hearing from you!
