Plant Microbiologist
The Plant Microbiologist is responsible for sterilisation programmes and procedures throughout the plant.
Responsibilities:
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Responsibility for the implementation and operation of the sterilisation programme including validation and re-validation of contract sterilisation, release of products following sterilisation and routine scheduling of sterilisation cycles
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Responsibility for the implementation and operation of the microbiological programme including bio burden and environmental monitoring programmes and flagging any issues in a timely manner
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Performing product assessment against biocompatibility requirements in relevant standards
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Responsibility for implementing regulatory requirements
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Responsibility for completing appropriate microbiology requirements as part registration of products in various markets
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Preparation, execution and analysis of related Quality documentation
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Support the internal audit program
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Involvement and general support to the Quality group including execution of assigned projects
Qualifications/Requirements
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Third level Qualification in Microbiology with at least 5 years experience in a similar role
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Thorough knowledge and experience of a regulated industry, including GMP, GDP, GLP
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Knowledge of medical device quality standards/practises or similar regulated industry