Description

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.<h3></h3><h3>The Position</h3>Principle Roles & Responsibilities / Accountabilities Implement GMP compliance against global GMP standards and China GMP requirement<ul><li>By assisting MB lab. Manager to conduct GMP Self- Inspection, and follow-up the implementation action to maintain the global level of GMP compliance.</li><li>By maintaining the quality system and documentation system to ensure quality system operations in QC meet the regulatory. </li><li>Support or conduct the commenting on CHP monograph.</li><li>Perform quality risk management and planned event.</li></ul>Implement microbial method transfer and verification<ul><li>Maintain the analysis method to be current and effective. </li><li>Coordinate the new method validation or transfer in MB lab. </li><li>Implement the defined analysis method validation via planning, executing and reporting process.</li><li>Perform method periodical review timely. </li></ul>Implement the maintenance, calibration and qualification of assigned instruments(Isolator, incubator, Genetic analyzer 3500, etc.) to ensure they are in good order to meet the analytical needs any time.<ul><li>By keeping the relevant document to trace the calibration, maintenance history and any change of the instruments.</li><li>By keeping contact with instrument company to obtain the sufficient application technical support and repair service in time.</li><li>By keeping contact with instrument company to obtain the repair service in time. </li><li>By keeping the validated state via close working with lab support, quality validation team.</li></ul>Complete the assigned routine inspection of sample, issue the reliable analytical report in reasonable lead time.<ul><li>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.</li><li>By rationalize time allocation, optimizing combination the samples in hand, to keeping the reasonable lead time.</li><li>By form a good working habit to standardize experimental operations.</li><li>By checking analysis result serious and careful to minimize mistakes and ensure accuracy and reliability of testing figures.</li></ul>Report the abnormal status, unexpected results to supervisors with initiative and in time.<ul><li>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.</li><li>By leading the investigation precession to identify the actual data and information, and try to find the cause to helping to provide the same issue happened repeatedly.</li></ul>Effectuate management of sample distribution and analytical process inspection to ensure timely releases of analytical report to support business need.<ul><li>By managing working schedule of relative section according to site production planning, to optimize utilization of human resources.</li><li>By monitoring the analysis process to push the analytical report issued in reasonable lead time.</li><li>By monitoring the timely calibration and maintenance of instrument within working section, ensure keeping in good order.</li><li>By monitoring the timely logged, complement of reagents, vessel, reference standard substances, etc. in working section, to ensure sufficient supply.</li></ul>Review and approve analytical record and analytical report.<ul><li>By establishing the standard template analytical record, guide and train analyst using the correct documentation system.</li><li>By updating the standard template analytical record, according to current available method of analysis and specification, providing updated documentation system.</li><li>By reviewing the analytical record and analytical report, correct shortage, ensure the right documentation. </li></ul>Guide and train the analysts on test skills, using, cleaning and maintenance of instrument.Stick lab safety regulations to prevent occurrence of accident.<ul><li>By obey the safety instruction of the storage, usage and disposal of reagent, narcotics, medicines, lab waste.</li><li>By following the usage instruction of facilities of water, electricity and steam etc. in lab.</li><li>By guiding colleagues to follow company safety rule, and patrol working section at the end of working day to secure the safety of lab.</li></ul>Qualification and Experience Education/Qualifications<ul><li>Bachelor of Science Degree or above </li><li>Pharmacy, Microbiology, Biochemistry and equivalent </li><li>At least 6years’ experience in Quality Control Unit of major or joint venture Pharma Company</li></ul>Leadership Competencies<ul><li>Models Integrity</li><li>Focus on value and customer </li><li>Align for success </li><li>Deliver results </li><li>Learn for the future </li></ul>Job Required Competencies<ul><li>Professional knowledge of microbiology and bioassay analysis</li><li>GMP implementation experience and sense</li><li>Project management skills </li><li>Cross-functional communication </li><li>Language skills – English & Chinese </li></ul> <h3>Who we are</h3>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.

Associate Manager or Manager of MBEM Lab

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Roche

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