Initial 12-month contract role. Days (usually 8am~4.30pm). Onsite role. 


Assuring that non-conformance investigations, laboratory investigations and quality systems are in compliance with the good manufacturing practices. Good laboratory practices as established in the code of local government regulations and company procedures.


  • Perform routine environmental monitoring, product testing in line with company and regulatory specifications and trend associated data
  • Perform routine testing on water purification systems in line with company and regulatory specifications and trend associated data
  • Perform Quality Control on incoming media and test kits.
  • Perform microbial identifications to ensure compliance with procedure and regulatory requirements
  • Perform validation and annual re-qualification of production Sterilisers and calibration of Validation equipment and document-associated data
  • Complete Annual re-qualification of laboratory Steriliser.
  • Perform Process / Equipment / Facilities and Utilities Validation and document associated data
  • When required, Review and report Steriliser Non-conformances
  • Perform monthly run review of production sterilisers performance using statistical tools
  • Implement improved methodologies/processes for Lab processes
  • When required Perform microbiology assessment on engineering changes
  • Carry out safety inspections
  • Training of new microbiology laboratory technicians
  • Providing Japan Distribution with Sterility Certificates for product
  • Ensure Lab is supplied with consumables.
  • All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.
  • Creating, implementing and assessing change requests.
  • Sterilizing and disposing of laboratory waste.


  • A level 8 or higher degree in a science or relevant field.
  • Minimum 1yrs previous experience, preferably within medical devices or pharma.
  • Good knowledge of FDA and ISO requirements
  • Good organization skills and familiarity with computer packages.

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