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The Position

Roles & Responsibilities

Routine Operation:

Implement GMP compliance against global GMP standards and China GMP requirement

• By assisting the Head of Analytical Testing 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.

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 the supervisor to investigate and solve the problem in the 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 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 analysis data to feedback improve opportunity.

As the experienced SME proactive drive the continuous improvement in Analytical Testing lab by leading the taskforce to identify and implement new technologies to improve the compliance and efficiency in routine QC operations.

Engineering Project Support and Operation Readiness:

Analytical Transfer Support: Support the establishment of the product control strategy and implement Analytical Transfer activities.

Analytical method validation and qualification: Support and establish analytical method validation activities and perform method monitoring.

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

Qualification and Experience

Education/Qualifications

• Bachelors 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 protein analysis in pharmaceutical industry. 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 analytical method transfer and validation.

• 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 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.