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Associate Director Microbiology / Site Microbiologist

Date: Sep 22, 2022

Location: Runcorn, GB, WA7 3FA

Company: Teva Pharmaceuticals

Position Overview

We won’t just give you something to do as a role within quality. We will give you something to work towards, a cause to pursue...

 

Job Description

We are currently recruiting a Associate Director Microbiology / Site Microbiologist (as a combination role) to join the team in Runcorn on a Full Time, Permanent basis.

 

Main purpose of the role:

Associate Director Microbiology / Site Microbiologist will be responsible for leading the site in Microbiology, ensuring that all appropriate microbiological standards and regulatory requirements are met. You will also lead and support the QC Microbiology laboratory to provide a compliant, on time testing service to the site to ensure all required microbiological testing is performed to plan and in accordance with approved procedures and test methods e.g. starting materials, components, packaging materials, intermediates, bulk and finished product and utilities.

You will 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 and provide your technical expertise and leadership to Operations for all aspects of sterile manufacturing as appropriate.

 

Key Responsibilities:

  • Through a high profile presence, both personally and by the Microbiology Department, 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.

  • Lead the QC Microbiology laboratory to provide a compliant, on time testing service to the site.

  • Develop and maintain quality systems for QC Microbiology including specialised training and microbiological specifications for environmental monitoring, utilities, raw materials, components, in-process and finished product, to ensure that tests meets both Teva and Regulatory agency policies, guidelines and the registered Marketing Authorisations/Dossiers.

  • Recruit, train, motivate and develop Microbiology technicians to enable them to achieve their full potential, and that of the Microbiology team.

  • Analyse trends from microbiological data and prepare 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

Qualifications

  • Degree qualified in an allied Life Science discipline

Knowledge, Skills and Abilities Required

  • Significant experience of pharmaceutical microbiology; a portion of which should have been gained in a leadership 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.

  • Well-developed communication skills with the ability to persuade and influence all levels of colleagues, regulators and industry specialists

  • Strong leadership skills with the ability to develop talent and tackle underperformance whilst maintaining teamwork and commitment

  • Hold the highest standards of integrity, especially in decision making and the application of standards

  • Experience with testing biologic products

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

 

This position will be open for internal applicants until Sunday 25th September

Teva’s Equal Employment Opportunity Commitment

At Teva, we pride ourselves on being a company where we can all thrive, and where everyone feels comfortable being their true self.

Diversity and inclusion sits at the heart of everything we do. By valuing difference, we can be a better employer for our colleagues, and provide a better service for our customers and patients. That is why we are constantly looking for ways in which we can learn from each other, embrace what makes us unique and contribute to a fairer society free from discrimination and prejudice.