Associate Manager or Manager of MBEM Lab

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Implement GMP compliance against global GMP standards and China GMP requirement.

• Assist the MB lab manager in conducting GMP Self-Inspection and follow up on implementation actions to maintain global level of GMP compliance.
• Maintain the quality system and documentation to ensure QC operations meet regulatory requirements.
• Support or conduct commenting on CHP monograph.
• Perform quality risk management and planned events.

Implement microbial method transfer and verification.

• Maintain current and effective analysis methods.
• Coordinate new method validation or transfer in MB lab.
• Implement defined analysis method validation via planning, execution and reporting.
• Perform periodic method review in a timely manner.

Implement the maintenance, calibration and qualification of assigned instruments (Isolator, incubator, Genetic analyzer 3500, etc.) to ensure they are in good order to meet analytical needs at all times.

• Keep relevant documentation to trace calibration, maintenance history and any instrument changes.
• Maintain contact with instrument company to obtain sufficient application technical support and repair service in a timely manner.
• Maintain contact with instrument company to obtain repair service in time.
• Maintain validated state via close collaboration with lab support and quality validation team.

Complete the assigned routine inspection of sample and issue the reliable analytical report within a reasonable lead time.

• Master analytical methods within the working section, comply with professional morality and etiquette to ensure reliability and integrity of analytical data and maintain excellent working capacity.
• Rationalise time allocation, optimising sample combination to keep a reasonable lead time.
• Develop good working habits to standardise experimental operations.
• Check analysis results carefully to minimise mistakes and ensure accuracy and reliability of testing figures.

Report abnormal status, unexpected results to supervisors with initiative and in time.

• Report abnormal status and unexpected results during analysis processing at first opportunity with detailed data and information to alert supervisor to investigate and solve the problem correctly and promptly.
• Lead the investigation process to identify actual data and information, and find the cause to help prevent repeated issues.

Effectuate management of sample distribution and analytical process inspection to ensure timely release of analytical reports to support business needs.

• Manage working schedule of the relative section according to site production planning to optimise utilisation of human resources.
• Monitor the analysis process to push the analytical report issuance within a reasonable lead time.
• Monitor the timely calibration and maintenance of instruments within the working section, ensuring they remain in good order.
• Monitor the timely logging and replenishment of reagents, vessels, reference standards, etc. in the working section to ensure sufficient supply.

Review and approve analytical record and analytical report.

• Establish the standard template analytical record, guide and train analysts using the correct documentation system.
• Update the standard template analytical record according to current available methods of analysis and specifications, providing updated documentation system.
• Review the analytical record and analytical report, correct shortages, and ensure correct documentation.

Guide and train analysts on test skills, instrument use, cleaning and maintenance.

Stick to lab safety regulations to prevent accidents.

• Obey safety instructions for storage, usage and disposal of reagents, narcotics, medicines and lab waste.
• Follow…