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Site Microbiologist Lead

2 months ago


Runcorn, Halton, United Kingdom Teva Full time
About the Role

We are seeking a highly skilled and experienced Site Microbiologist Lead to join our team at Teva. As a key member of our organization, you will play a critical role in ensuring the quality and safety of our sterile products.

Key Responsibilities
  • 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.
  • Monitor developing regulatory and industry requirements and practices enabling Teva to introduce new products and processes in an efficient and compliant manner.
  • Implement, monitor, and maintain appropriate standards of control over process, personnel, environment, and utilities to demonstrate compliance with all regulatory and Teva standards.
  • Analyze trends from microbiological data and collaborate with QC Microbiology in preparing periodic trend reports with appropriate recommendations for remedial/corrective actions where necessary.
  • Provide expert review and oversight of all aspects of sterile manufacture at Teva 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.
Requirements
  • Degree qualified in a Microbiology discipline.
  • Significant experience of pharmaceutical microbiology, with 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 clean room design and environmental monitoring, advanced aseptic techniques using isolators or RABS, sterilization technologies, rapid microbiological methods, cleaning and disinfection, microbial taxonomy and identification, and water systems.
  • Evidence of continuing professional development of a microbiology function.
  • 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.
What We Offer
  • A competitive salary.
  • A formal training and development program specific to your role and department.
  • A company pension with flexible employee and employer contributions.
  • A private healthcare scheme through Bupa for you and your partner.
  • A number of health benefits, including life assurance, critical illness insurance, and income protection.
  • A range of flexible benefits via salary sacrifice, including a cycle to work scheme and online and in-store discounts.