Sterility Assurance Specialist

Sterility Assurance Specialist

Baxter International

Lund, Sweden

Summary

The Sterility Assurance specialist will provide technical expertise and support to the DVM Process for all sterility assurance aspects. He/she will act as a valuable and effective source of information and advice on sterility assurance and will positively contribute to the DVM Lund Quality Management Team. He/she will be responsible for ensuring that the DVM Lund maintain a robust, effective and compliant sterility assurance and environmental control and monitoring process in conjunction with the global strategy.

Essential Duties and Responsibilities

  • Responsible for ensuring effective sterility assurance and environmental monitoring programmes are deployed in the DVM facility in compliance with current GMP and the Baxter global strategy.
  • Supporting the Global compounding organization on standardization of sterility assurance practices and identification/implementation of new technology for microbiological testing and environmental control.
  • Participation in continuous improvement projects and providing the expert guidance and assessment for the questions related with Sterility insurance, including risk reduction initiatives in line with company strategy.
  • Support and lead problem solving investigations for product and process deviations or customer complaints.
  • Provide coaching and mentoring to other functions in problem solving with respect to Sterility Assurance.
  • Participate in the DVM Lund complaints investigation, Nonconformance and quality incidents investigation, act as technical approver.
  • Provide technical support in interpretation of Microbial Identification and Environmental Monitoring data and for the trending of EM and Microbiological data including setting of appropriate Alert limits.
  • Responsible for the Tracking and Reporting or Quality Metrics for internal and external use.
  • Carry out validation and experimental design in association with EMEA Sterility Assurance Manager.
  • Qualification, Auditing and monitoring the service Levels of external Lab, providing the proper oversight on technical aspects.
  • Support the development of the quality documentation including local SOP’s, approval of documents related with Sterility Assurance as Technical Approver.
  • Providing Microbiological training and Aseptic Operator Training for operational and quality staff including periodic reassessment.

Qualifications

  • Degree in Microbiology, although others may be considered with relevant experience;
  • Required 2 years’ experience in implementing environmental control programs, OOL investigation and correction and support to aseptic or similar clean room environments;
  • Preferred 3 to 5 years’ experience of microbiology experience in an aseptic facility;
  • Must have strong operational experience preferably in an aseptic manufacturing background, sterile manufacture or similar Medical Device or Biopharmaceutical background;
  • Experience of aseptic technique;
  • Have excellent interpersonal skills and strong influencer;
  • Be a passionate advocate of quality as a discipline and continuous improvement;
  • Have experience in the use of quality improvement and problem-solving skills (ie FMEA, DMAIC, Process Mapping etc.) and the interpretation of data, experience of Lean manufacturing;
  • Have experience of critical equipment and process Change Control;
  • Have experience of validation of microbiological methods or sanitization processes;
  • Able to work autonomously and take the initiative;
  • Demonstrate:
    • Critical thinking and decision making;
    • Collaboration and teamwork;
    • Dealing with ambiguity;
    • Good management and communication skills;
    • Customer and patient focus.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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