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.
DUTIES & RESPONSIBILITIES
- 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.
EXPERIENCE & EDUCATION
- 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.