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Responsible for environment monitoring, sampling and testing of water, particles and compressed air.
Responsible for microbiological testing of raw and packaging materials, bulk, semi-finished and finished products, water, air, premises, gowning and equipment.
Responsible for microbiological testing of all products that undergo stability studies.
Perform duties in accordance with Malia Group Policies and Procedures.
On Microbiology Testing & Documentation
- Manage and maintain the documentation system of the micro lab according to GMP "Good Manufacturing Practices" principles
- Prepare and update specifications, certificate of analysis and microbiological test methods
- Prepare equipment calibration, verification and operating instructions
- Conduct calibration for microbiology lab equipment
- Plan and coordinate with concerned for timely microbiology lab equipment maintenance
- Conduct tests for qualification and validation of lab equipment and test methods; prepare validation protocol and report for microbiology method validation
- Participate in microbiological cleaning and process validation tests
- Report to Quality Control Manager all out-of-specifications, out-of-trends, change control, risk assessment and deviations
- Perform microbiology analysis tests as per product specification
- Perform microbiology and analytical tests for water from all points of use
- Perform microbiological tests for air in all production areas (manufacturing and filling) microbiology lab and sampling room; perform compressed air and particles testing as well as active air sampling and testing in different plant areas as per set schedule
- Conduct sampling and testing of products for release and shelf life; report all results to Quality Control Manager
- Report all tests results to the Quality Control Manager along with related CAPA when needed
- Investigate and adjust with concerned any microbiological failure
- Coordinate with the Quality Control and Quality Assurance Managers for the disposal materials and products
- Provide necessary microbiological awareness to all plant staff to ensure that operations are performed in compliance with quality requirements; make sure that microbiological procedures are understood and implemented
- Update product microbiological specifications in accordance with the latest references
- Perform validations for microbiology test methods and equipment
- Monitor and control the stock of reagents and media needed for micro analysis; coordinate with QCM to set purchase request
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