Microbiologist & Sterility Assurance

About the role

Control of manufacturing environment, sterility assurance of all products, and site microbiologist for all microbiological testing. Point of contact with outside laboratory test and sterilization services, working under advice of Micro & Sterility Assurance Subject Matter Expert (SME) to conform with all corporate requirements.

Key responsibilities

• Implement and control all microbiological, sterilization follow requirements in QMS procedures.
• Establish schedule of all monitoring items in the plant and control all monitoring items to perform as planned.
• Ensure Microbial monitoring in production area conform with requirements i.e Surface Adhering, Environment Air, Compressed Air.
• Ensure Particle counts monitoring in production area conform with requirements.
• Ensure Microbial monitoring of water system and compressed air conform with requirements.
• Ensure Bioburden testing of pre-sterilization products conform with requirements.
• Isolation and identification of unusual microbial contaminants, identification of their sources and making recommendations for their eradication.
• Execute failure response actions of any microbiological and sterilization failures.
• Ensure the working areas are cleaned and met the microbiological requirement procedure.
• Ensure Sterilization processes performed by contract sterilizer conform with requirements to release products.

About you

• Bachelor's degree in microbiology or related field, preferred
• 2-4 years working experience in microbiologist and/or quality control in large manufacturing company is preferred
• Leadership skills and Team player
• Effective problem solving and analytical skills, and able to lead and influence others to drive improvements
• Good knowledge in risk analysis and risk management
• Good knowledge and practice of Corrective action & Preventive action program.
• Experience in quality system in medical devices business
• Knowledge of international standard ISO 13485 or ISO 9001 or MDSAP and other requirements e.g., ISO 14971 Risk management, ISO 11135 EO sterilization, ISO 11137 Radiation sterilization
• Native Thai speakers
• Good command in English and Computer skill (Microsoft Word, Excel, PowerPoint)