Location: Nakorn Pathom, Thailand

Reports to: Quality Compliance Manager

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)

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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