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Plant Microbiologist Career Profile
Plant Microbiologist
The Plant Microbiologist is responsible for sterilisation programmes and procedures throughout the plant.Responsibilities:
- 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
- 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
- Performing product assessment against biocompatibility requirements in relevant standards
- Responsibility for implementing regulatory requirements
- Responsibility for completing appropriate microbiology requirements as part registration of products in various markets
- Preparation, execution and analysis of related Quality documentation
- Support the internal audit program
- Involvement and general support to the Quality group including execution of assigned projects
- Third level Qualification in Microbiology with at least 5 years experience in a similar role
- Thorough knowledge and experience of a regulated industry, including GMP, GDP, GLP
- Knowledge of medical device quality standards/practises or similar regulated industry
