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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
Qualifications/Requirements
  • 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