Cork - STERILITY ASSURANCE COMPLIANCE SPECIALIST

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Reporting to the Sterility Assurance Manager, the primary purpose of this position is to ensure efficient and cost effective Sterility Assurance compliance. This includes developing, implementing, managing and continually improving Sterility Assurance activities to ensure that GE Healthcare is in compliance with current European and FDA requirements. Essential Responsibilities To be fully conversant with GMP requirements and changing requirements for site wide European and FDA Sterility Assurance Compliance in a parametric release environment.To identify, implement and provide guidance on improvement opportunitiesBreak out segments of Sterility Assurance to interpret, define and optimise global requirements. To ensure the data and controls are in place to meet these requirements and build knowledge opportunities across the site.Help develop educational resources and optimise Sterility Assurance awareness throughout the site.Develop and coach department members and the wider community where appropriate Deputise for the Sterility Assurance Manager as requiredPresent and defend Sterility Assurance data to auditors.Review relevant documentation such as plans, protocols and reports as required and ensure that they are generated and completed in accordance with defined procedures / sta ...

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