Microbiologist & Sterility Assurance

Position Summary

• Control of manufacturing environment
• Sterility assurance of all products
• Site Microbiologist for all microbiological testing
• Control and point of contact with outside laboratory test and sterilization services
• Work under advice of Micro & Sterility Assurance Subject Matter Expert (SME) to conform with all corporate requirements

Job Description

• 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.
• Perform Sterilization validation/ re-validation and establish protocol & report.
• Coordinate with Production to perform product loading for sterilization validation.
• Coordinate with CAH lab to perform Dose audit to be completed as established interval plan.
• Coordinate with contract sterilizer for validation and routine sterilization control.
• Evaluate all changes related to product, environment and process in the plant and communicate to Corporate Subject Matter Expert.
• Consult with Corporate Subject Matter Expert of microbiological, sterilization.

Qualification & Requirements

• Bachelor’s degree in microbiology or related field, preferred
• Leadership skills and Team player
• 2-4 years working experience in microbiologist and/or quality control in large manufacturing company is preferred
• 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)