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The Position

Principle Roles & Responsibilities / Accountabilities

Adhere to current GMP requirement of Roche PMS, Chinese GMP regulatory, and apply the requirement of cGMP and implemented in daily routine work.Complete relevant training according to Roche requirements.By maintaining the documentation to ensure quality system operations in QC meets the regulatory.By maintaining the documentation to ensure quality system operations in QC meets the regulatory.Ensure that the following works are effectively executed to support LS and QC related businessLocal instrument/equipment aspect, including but not limit to:Management of the lifecycle process for instrument/equipment and execution of related business operations, including verification/validation of instrument/equipment, periodic review, backup/archive/recovery, internal and external calibration and testing, decommissioning, maintenance and repair, contracts and orders, etc.Roche Global system aspect, including but not limit to:Roche global systems directly associated with testing such as SingleLIMS, NEXTLab, Labx, Empower, GSMP. Including creation of user processes, using and maintenance; Creation of Master Data/Method and it's processes, using and maintenance etc.Roche global systems indirectly associated with testing such as ECM, VOMOBA, ARET. Including creation of user processes, using and maintenance etc.Budget and CAPEX aspect, including but not limited to:Annual EA assessment, CAPEX and budget management and annual procurement planCommunication and cooperation with other QC teams and relevant departments, including but not limited to:Collaborate with the QV on the effective implementation of instrument/equipment qualification/validation processes in QCCollaborate with the Maintenance& Calibration to effectively implement the instrument/equipment calibration processes in QC.Collaborate with Procurement and EQ about the reagent/consumable, instrument/equipment, and maintenance/repair services business.Collaborate with MAST on QC fixed assets and annual procurement plan.
Collaborate with other internal/external department to support other business of Roche.Support QC Digital Transformation.Support Roche QC e-system local implementation, collaborate with Roche project team and IT and end user, participate in the process development and defining, SOP writing and MD maintenance etc.Regularly review and continuously optimize Roche QC digital system to ensure supporting the constantly changing business processes.Support IT system maintenance and upgrade.Project Management & Continuous ImprovementSupport QC project management and objective management, e.g. Project management capability establish and refresh, project portfolio management and follow-up.Understand the Lean Lab management concept and LPS tools, to apply relevant concepts to continuously improve in routine work.Continuous improve the lifecycle management strategy of equipment and system.Laboratory Data Integrity Assurance.Understand lab DI with Roche standards, and implement it in routine work and promote DI requirements.Provide guidance and training regarding data integrity assurance to QC.Ensure QC E2E data integrity based on risk, process and data lifecycle.Complete the other tasks assigned by leader.

Qualification and Experience

Education/ Experience/ Qualifications

Bachelor of Science Degree or abovePharmacy, Chemistry, Biochemistry and equivalent5 or more years’ work experience in the pharmaceutical or related industry2 or more years’ people management experience3 or more years’ quality, compliance or other relevant experience in the pharmaceutical industry

Leadership Competencies

Be able to choose appropriate communication ways based on different situations to support problem-solving and work delivery.Be able to help team to establish continuous learning and improvement working environment.

Job Required Competencies

Professional knowledge of physical & Chemical analysisGMP implementation experience and senseProject Management skillsKnowledge on Lean Production SystemKnowledge of management of laboratory instrument/equipmentLanguage skills – English & Chinese

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.