Sterility Assurance Specialist

Baxter ,
London, Greater London
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Job Description

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 A environment * OOL investigation and correction * Rapid methods * Sterility testing Job: **Quality* Organization: **Global Quality - Global Compounding Quality* Title: Sterility Assurance Specialist Location: GBR-London-Oxford Requisition ID: 190003DW

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