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Associate Manager – P/C Analytical Laboratory


Job title: Associate Manager – P/C Analytical Laboratory

Company: Roche

Job description: Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionPrinciple Roles & Responsibilities / Accountabilities

  • Performance of physical and chemical package material testing, excipients testing, product stability, release and in-process control testing and necessary trending analysis under Lean lab management.
  • Performance of testing in accordance with cGMP regulations and Roche/Genentech standards and China GMP requirement.
  • Supporting manufacturing operations by timely completion of package material testing and excipients testing.
  • 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 excellent capacity of working suitability.
  • By rationalize time allocation, optimizing combination the samples in hand, to keeping the reasonable lead time.
  • By form a good working habit to standardize experimental operations.
  • By checking analysis 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 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.
  • 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 precession to provide actual data and information to helping to provide the same issue happened repeatedly.
  • 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.
  • By following the usage instruction of facilities of water, electricity and steam 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.
  • Tutor subordinators to fulfill analysis tasks.
  • By providing technical support to analyst if necessary share knowledge and experience within working section.
  • Tutor subordinators to implement the analysis method validation.
  • By implement the assigned analysis method validation according to validation plan.
  • Have the 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 answer the problem of analyst and suggested in time.
  • To ensure the normal running of routine work.
  • Implement the out of control limit investigation and out of trend management work.
  • Accomplish the investigation of the result out of control limit and trend analysis management work within P/C Lab.
  • Review and approve assigned analytical data in instrument & LIMS system and paper analytical record.

Qualification and ExperienceEducation/Qualifications

  • Bachelor’s Degree (chemistry or other relevant discipline is preferred) .
  • Graduate or higher-level Degree is preferred.

Leadership Competencies

  • 4 or more years’ work experience in the pharmaceutical or related industry.
  • 3 or more years’ people management experience.
  • 3 or more years’ quality, compliance or other relevant experience in the pharmaceutical industry.

Job Required Competencies

  • Expert knowledge of analytical laboratory operations in support of commercial manufacturing.
  • Expert knowledge of cGMP relevant to the pharmaceutical industry.
  • Expert knowledge of laboratory safety procedures.
  • Expert knowledge of Quality System principles, practices and standards for the pharmaceutical industry.
  • Basic Knowledge in Pharmaceutical Microbiology.
  • Demonstrate strong verbal and written communication skills in English.

Who we areAt 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.Roche is an Equal Opportunity Employer.

Expected salary:

Location: Shanghai

Job posting date: Thu, 20 Jun 2024 22:11:06 GMT

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Associate Manager – P/C Analytical Laboratory

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Associate Manager – P/C Analytical Laboratory

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