Microbiology Lead （CCS EM)

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Roles & Responsibilities

Routine Operation:

Implement GMP compliance against global GMP standards and China GMP requirement

• By assisting Head of Microbiology lab to conduct GMP Self-Inspection, and follow-up the implementation action to maintain the global level of GMP compliance.
• By maintaining the quality system and documentation system to ensure quality system operations in QC meets the regulatory requirements.

Complete the assigned routine inspection of sample, issue the reliable analytical report in reasonable lead time. It includes the administration of environmental monitoring programs, material incoming test process validation and cleaning validation.

Implement the maintenance and calibration of assigned instruments 

• By accomplishing the calibration and maintenance of assigned instruments, to ensure they are in good order to meet the analytical needs any time.
• By keeping the relevant document to trace the calibration, maintenance history and any change of the instruments.
• By keeping contact with instrument company to obtain the sufficient application technical support and repair service in time.

Maintain the analysis methods to be current and effective.

• Implement the defined analysis method validation via planning, executing and reporting process.
• Perform method periodical review timely.
• Report the abnormal status, unexpected results to supervisors with initiative.
• By reporting abnormal status and unexpected results during analysis processing by detailed data and information to alert supervisor to investigate and solve the problem in correct way and in time.
• By leading the investigation precession to identify the actual data and information, and try to find the cause to help to prevent the same issue from happening repeatedly.

Stick lab safety regulations to prevent occurrence of accidents.

• By obeying the safety instruction of the storage, usage and disposal of reagent, narcotics, medicines, lab waste.
• By following the usage instructions of facilities of water, electricity and steam etc. in lab.

Tutor colleagues to fulfill analysis tasks

• By providing technical support to colleagues if necessary and sharing knowledge and experience within working section.
• By checking and reviewing the testing process and analyzing data to feedback improve opportunity.

As the experienced SME, proactive drive the continuous improvement in Microbiology lab  by leading the taskforce to identify and implement new technologies to improve the compliance and efficiency in routine QC operations, including test method execution, documentation updates and equipment qualification

Engineering Project Support and Operation Readiness: 

CCS Support: Support the establishment of the Contamination Control Strategy (CCS) for the aseptic production line.

Environmental Monitoring (EM): Support EMPQ and establish risk based environmental monitoring strategy and ensure its effective implementation.

Microbiology Method Validation: Responsible for the validation of microbiology methods, including supporting the confirmation of cleaning and disinfection processes, and the efficacy of disinfectants.

Equipment Support: Support the Performance Qualification (PQ) of laboratory equipment and ensure routine operation.

Qualification And Experience

Education/Qualifications

• Bachelor’s Degree (Life Sciences, Microbiology, or Analytical Sciences is preferred) and above 
• Special Equipment management certification

Leadership Competencies

• Models Integrity

• Focus on value and customer

• Align For Success

• Deliver Results

• Learn for the future

Job Required Competencies

• 3 or more years of QC experience, QC experience, with a focus on microbiology and aseptic processes. MNC Bio-pharma experience is preferred
• Sound knowledge of quality control procedures and legal standards, with experience in aseptic assurance and microbiological testing. Possess hands-on experience in Contamination Control Strategies (CCS) and Environmental Monitoring (EM) control strategies.
• Experience with compliance inspection by NMPA.
• Experienced in QC new facility startup readiness and operation ramp up is preferred.
• Fluent communications skills in English

• Project Management Skills

Who We Are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.