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Job description :
Responsibilities
- Establish and monitor the basic minimum standards required for microbiological and biochemical testing of sterile medical devices.
- Independently manages laboratory team in qualification of testing in harmonisation within the Company.
• Qualification protocols for all tests associated with manufacturing of sterile medical devices, including but not limited to product and packaging bioburden tests, sterility assurance tests, sterilant residual tests, and cleanroom environmental monitoring tests.
• Ensure that any outside consultants are properly selected and managed.
- Co-ordinates with Manufacturing and Quality Assurance departments in the timely release of devices and components for distribution
- Co-ordinates with Manufacturing in the development and validation of test method and sterilisation process to support site projects.
- Supervision of Laboratory Team and lead the microlab team in goal setting and achieving the set targets of the initiatives.
- Approve and implement methods of plant microbiological and hygiene control
- Ensure all products requiring sterilization are tested appropriately and verified for sterility following defined procedures
- Develop all microbiological test procedures, laboratory and sterilization validation programmes
- Conduct microbiological laboratory, critical component and contract sterilizer audits, and ensure documented sterilization procedure are provided
- Responsible for release of sterilized products
- Development of documented cleaning schedules and methods for relevant areas and equipment
- Development of documented procedure for isolation and basic identification of pre-sterilization microbiological contamination
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