Sterility Assurance Specialist
Oxford, UK
4d ago


Sterility Assurance Specialist

The Sterility Assurance specialist will provide technical expertise and support to the sites for 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 UK Compounding Quality Management Team.

He / she will be responsible for ensuring all sites maintain a robust, effective and compliant sterility assurance and environmental control and monitoring process in conjunction with the global strategy.

Role Responsibilities

Responsible for ensuring effective sterility assurance and environmental monitoring programmes are deployed in all UK Compounding Facilities, 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 the UK compounding projects and providing the expert guidance and assessment for the questions related with Sterility insurance.

  • Support and lead risk reduction and continuous improvement initiatives in line with company strategy;
  • Provide ongoing direct support by attending each of the UK sites on a regular basis.

  • Support and lead problem solving investigations for product and for UK sites process deviations or customer complaints;
  • Provide coaching and mentoring to other functions / sites in problem solving with respect to Sterility Assurance;
  • Participate in the compounding site complaints investigation, Nonconformance and quality incidents investigation, act as technical approver.

    Provide technical support in interpretation of Microbial Identification and Environmental Monitoring data.

    Provide technical support 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

    Provide Technical support for Microbiological laboratory in Thetford as and when required.

    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.


    Environmental monitoring in Grade Aenvironment

    OOL investigation and correction

    Sterility testing

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