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Principle Roles & Responsibilities / Accountabilities

Technical and Functional

• Complete adroitly the assigned routine inspection of sample, issue the reliable analytical report in reasonable Lead-time.
• By master analytical methods within working section, comply with professional morality and etiquette to ensure reliability and integrity of the analytical data and keeping the good capacity of working suitability.
• By rationalize time allocation, optimizing combination the samples in hand, to keeping the assigned lead-time.
• By form a good working habit to standardize experimental operations.
• By checking analytical result serious and careful to minimize mistakes and ensure accuracy and reliability of testing figures.

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

• By assisting lab. Manager to conduct GMP Self- Inspection, and executive 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.

Implement the maintenance and calibration of assigned instruments

• By accomplish 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.
• By keeping contact with instrument company to obtain the repair service in time.
• Report the abnormal status, unexpected results to supervisors with initiative and in time.
• By reporting abnormal status and unexpected results during analysis processing at first time by detailed data and information to alert supervisor to investigate and solve the problem in correct way and in time.
• By involving the investigation, provide actual data and information to helping to prevent the same issue happened repeatedly.
• By providing technical support to junior analyst, if necessary share knowledge and experience within working section.
• Stick lab safety regulations to prevent occurrence of accident.
• By obey the safety instruction of the storage, usage and disposal of reagent, narcotics, medicines, lab waste.
• By following the usage instruction of facilities of water, electricity, steam and etc. in lab.
• By clearing the working space in time to follow company safety rule, and patrol working section at the end of working day to secure the safety of lab.

Implement the analysis method validation

• By implement the assigned analysis method validation according to validation plan.
• Sampling of cleaning validation.
• Have the basic ability to find and solve the problems occurred in the routine work.
• To find the problems and solve the problems in correct way and in time during the analysis processing.
• To ensure the normal running of routine work.

Qualification and Experience

Education/Qualifications

• Bachelor’s Degree (biology, microbiology, biochemistry, chemistry or other relevant discipline is preferred)
• Graduate or higher-level Degree is preferred

Leadership Competencies

• 2 or more years’ work experience in the pharmaceutical or related industry
• 2 or more years’ quality, compliance or other relevant experience in the pharmaceutical industry

Job Required Competencies

• Good knowledge of analytical laboratory operations in support of commercial manufacturing.
• Good knowledge of c GMP relevant to the pharmaceutical industry
• Expert knowledge of laboratory safety procedures
• Strong knowledge of Quality System principles, practices and standards for the pharmaceutical industry
• Demonstrate basic verbal and written communication skills in English

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche China consists of the full value chain of Pharmaceuticals and Diagnostics fields, from early research, clinical development, manufacturing to commercialization. With more than 7,000 employees, Roche China is now working to develop itself into Roche's third global strategic center after Basel and San Francisco, and making sustained efforts to fulfill its long-term commitment to China, so as to meet Chinese patients’ unmet needs.