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Baxter, Microbiology Manager – Thetford

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About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

A Career That Matters

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.

Microbiology Manager

Site Microbiology Expert responsible for leading the Microbiology department ensuring the effective management of the Microbiology Laboratory in order to meet customer requirements both internally and externally and ensure all laboratory practices meet regulatory and corporate requirements, and providing overall Sterilisation Assurance oversight to the processes to ensure compliance with the cGMP requirements for the manufacture of Sterile Medicinal Products as well as with Parametric Release requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Managing the Microbiology QC Laboratory

  • Ensuring appropriate facility, processes and personnel are available for microbiological testing in line with cGMP and Baxter Global requirements;
  • Ensuring laboratory personnel is trained and qualified as appropriate for competency in microbiological testing;
  • Ensuring Safety Risk Assessments are in place for all laboratory operations and processes exist to ensure compliance to legal and Baxter Global EHS requirements;
  • Operating within budgetary requirements and continuously driving for budget efficiency;
  • Driving a culture of continuous improvement within the laboratory by ensuring process performance and compliance improvement programs for the Microbiology Laboratory are identified and implemented;
  • Ensuring non-conformances impacting Microbiology Laboratory processes and initiated and investigated in compliance with Thetford local procedures, Baxter global requirements and
    relevant regulations;
  • Ensuring regulatory and industry listening programs are place for the identification of best practices, regulatory trends and potential new technology and standards;
  • Ensuring learnings from investigations, benchmarking and regulatory/industry listening activities are adequately institutionalized;
  • Providing coaching and mentoring to all laboratory team members;
  • Hosting regulatory inspections as senior Subject Matter Expert (SME) and participate upon request in local and interplant internal audits as SME;
  • Ensuring appropriate standards of cGMP and EHS are maintained at all times;
  • Ensuring timely completion of all Quality System commitments;

Managing the Sterility Assurance function

  • Ensuring microbiological out of limits and out of trend results, as well as non-conformances impacting sterility assurance are fully investigated in compliance with Thetford local procedures, Baxter global requirements and relevant regulations;
  • Ensuring a Real-time Risk Assessment Program is in place to perform the routinely review of the manufacturing facilities, equipment and processes and appropriate actions are taken to continuously eliminate or mitigate microbial contamination risks;
  • Ensuring any atypical sterilisation cycles are reviewed and dispositioned by authorized and competent personnel;
  • Ensuring all sterilisers on site are appropriately initially and periodically qualified and the sterilisation process is maintained in a validate state;
  • Ensuring all clean room are appropriately initially and periodically qualified and performance is maintain to satisfy Annex 1 requirements as appropriate;
  • Ensure expertise is provided to impact assess changes affecting aspects relating to Sterility Assurance
  • Ensuring all documentation associated with Parametric Release (Real-Time Release) is maintained as required;
  • Ensuring a Sterility Assurance Review takes place with Site Senior Management to review the relevant indicators and trends that demonstrate an ongoing state of control with relation to sterility assurance and determine the need for further actions;
  • Ensuring learnings from investigations, benchmarking and regulatory/industry listening activities are adequately institutionalized;
  • Ensuring coaching and mentoring are provided to personnel in relation to Sterility Assurance philosophy and requirements;
  • Participate upon request in local and interplant internal audits as Subject Matter Expert;
  • Ensuring appropriate standards of cGMP are maintained;
  • Timely completion of all Quality System commitments;
  • Timely communication of significant EHS, GMP and/or product quality issues to Site Management;
  • Hosting regulatory inspections as senior Subject Matter Expert (SME) and participate upon request in local and interplant internal audits as SME;
  • Ensuring appropriate standards of cGMP and EHS are maintained at all times;
  • Ensuring timely completion of all Quality System commitments;

EDUCATION/EXPERIENCE REQUIREMENTS

Education – Degree in Microbiology or equivalent as a minimum

Experience

Breadth & Depth of experience: More than 5 years proven experience within a healthcare manufacturing environment in the EU and strong knowledge of EU GMP, Ph. Eur. and relevant ISO standard requirements Field of expertise: Sterile manufacture, with preference for experience in moist heat terminal sterilisation.

To apply, please click on the link below

http://adtrk.tw/tp/rj6-OdmD.I.K

or

https://www.baxter.com/careers