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The Position

Ensure quality & regulatory compliance of products manufactured in SRPL by effective management of Quality Control system functions in meeting business goal of company. Provide best practice such as GMP and GLP in Labs to compliance the current global standards.

General

Managing validation, qualification, and transfer and troubleshooting of analytical methodologies according to current Roche / Genentech requirements and regulations.Ensure pharmacopeia compliance in site and support ChP compliance across networkManage the sample and reference standard to meet the testing needs in site and in China areaManage the stability program to support China business Supporting and executing QC activities related to process and cleaning validation, special analytics, investigations and non-routine testing.Managing analytical trending process in labs according to current Roche / Genentech requirements and regulationsDeveloping and implementing the new technology roadmap, in collaboration with other QC labs and Global functions or PTD.

Implement GMP compliance with global GMP standards and China GMP requirement

Sample receipt, storage, distribution and disposal procedure management.Reference and retention sample management.Excute analytical transfers and local analytical method verifications.Ensure process and cleaning validation analysis execution.Maintenance of QC specifications and analytical methods.Packaging material standard sample management.Maintenance of Master Method Validation Plan and the timely execution of method validation protocols and reportsThird party QC labs managementProvide technical guidance on test methods and relevant procedures.Ensure support on manufacturing operations through troubleshooting and other product lifecycle testing.Manage the trending process in labs according to Roche PQS requirements and regulationsEnsure that CMC regulatory submissions are aligned with QC specifications and analytical methods.Ensure that QC specifications and analytical methods comply with applicable pharmacopeias requirementsSupport Chinese Pharmacopeia commenting and implementation across the networkStability program - chamber management, coordination with global and laboratories for timely execution of stability protocols and stability report, stability trendingQC metrics generation and report, managing performance of quality system processes (TCM, Discrepancies, CAPA, etc) for QCReference standards managementProvide QC technical support and oversight to CMO activitiesSupport regulatory inspections and partner audits

Who we are

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.

Roche is an Equal Opportunity Employer.