(Sr.) Specialist, LS & ASAT, Biologics

Job 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. The Position Roche is hiring for a greenfield facility in Shanghai and we are looking for Lab Support & ASAT SME, for who takes responsibility for equipment/systems qualification and validation, sample and testing material management and other lab supporting processes. Also provides support during the project, operation readiness and start-up phase and liaises across the design, construction, qualification of the QC area, ensuring they meet the intended standard and regulation requirements. Strong skill and experience are required to cover two areas: Greenfield project and Routine Operation management. The role supports on the equipment/system qualification and validation, sample/material management and QC operation readiness and start up. Work independently and with a level of autonomy and authority in efficient execution to ensure on-going compliance against approved global/local procedure documents, current Good Manufacturing Practices, and CN/EU Annex-1 during the product lifecycle. Enable and self-motivate, and demonstrate leadership behavior and mindset Principle Roles & Responsibilities / Accountabilities 主要职责 / 责任 Routine Operation: Perform the qualification, validation, calibration and maintenance activities for relevant equipment with Roche’s QMS and regulatory guidelines. Set up master data according to business requirements and ensure data integrity. Adhere to all effective SOPs and safety requirements and document laboratory work consistent with cGMP requirements Assist Head of Lab Support to complete GMP Self-Inspection as well as the relevant CAPAs to maintain the global level of GMP compliance. Presents technical analytical data clearly and concisely to internal investigations and regulatory inspectors. Accomplish sample and testing materials management(eg account management, DI assessment), to ensure they are in good order to meet the analytical needs any time. Report the abnormal status, deviations to supervisors with initiative. By identifying abnormal status and unexpected results during routine operation by detailed data, support to alert supervisors to investigate and solve the problem in correct way and in time. Maintain laboratory cleanliness and inventory of bioanalytical materials and cell supplies Supports lean initiatives in the area of lab operations, test method execution, documentation updates and equipment qualification Engineering Project Support and Operation Readiness: Equipment qualification and validation: Support and execute the equipment qualification and validation for the aseptic product. Sample and material management: Execute GMP sample management; Execute material inventory management. Digital system deployment: Support and ensure on time delivery for QC digital system(eg.LIMS). Qualification and Experience 能力与经验 Education/Qualifications Bachelor’s Degree (Life Sciences, Microbiology, or Analytical Sciences is preferred) and above Job Required Competencies 2 or more years of QC experience, QC experience, with a focus on bioanalytical and bioassay testing. MNC Bio-pharma experience is preferred Sound knowledge of quality control procedures and legal standards, with experience in aseptic assurance and physical and chemical testing. Experienced in QC new system startup readiness and operation ramp up is preferred. Fluent communications skills in English Project management skills are preferred. Who we are 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.