锦鲤求职岗位描述
在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。
职位
Roche is hiring for a greenfield facility in Shanghai and we are looking for Lab Support & ASAT AM, for who takes responsibility for QC equipment and digital systems, driving lean laboratory management, sample and testing material management,and other lab supporting processes. Also provides support during the project, ensuring both physical and electronic setups meet intended standards and regulatory requirements.
Strong skill and experience are required to cover two areas: System Master Data maintenance and Routine Operation.
● The role supports on the equipment/system qualification and validation, sample/material management and QC Routine operation.
● 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:
● Oversee and manage the qualification, Computerized System Validation (CSV), calibration, and maintenance programs for relevant laboratory equipment and electronic systems, ensuring strict adherence to Roche’s QMS and regulatory guidelines.
● Direct daily QC support operations, as well as manage and review relevant CAPAs to maintain a global level of GMP compliance. Present technical & system procedure clearly and professionally to internal stakeholders and regulatory inspectors.
● Govern sample and testing management systems(eg account management, DI assessment), to ensure they are in good order to meet the analytical needs any time.
● Guide the team proactively identifying abnormal statuses, deviations, and unexpected results based on detailed data analysis. Lead critical investigations to resolve problems correctly and timely, and effectively escalate major issues to senior management.
● Ensure all necessary processes, documentation (SOPs), and tracking systems are in place and executed Complianced.
● Ensure audit readiness by complying with effective standards, regulatory/statutory, and cGMP requirements. Provide technical support on all lab-related topics during internal and external audits.
● Support all QC activities during regulatory inspections and audits and participate in the response to regulatory and global quality audits.
System Management & Lean Lab:
● Set up master data according to business requirements and ensure data integrity.
● Digital system deployment: Support and ensure on time delivery for QC digital system(eg.LIMS).
● Lead QC system and electric record development according to the project plan and requirment in alignment with Roche standards.This involves creating a maintenance management system, and an automation strategy(eg. LIMS, Empower, SAP) and implementation to support robust operational readiness.
● Ensure the QC data flow generated by lab equipment/system and maintenance activities are compliance to DI requirements.
● Lead the QC Data Integrity (DI) Governance program: Establish and oversee robust DI control strategies, including routine audit trail reviews, DI risk assessments, and user access management. Ensuring all laboratory processes, electronic systems, and raw data generation strictly comply with ALCOA+ principles and global regulations.
● Ensure all data is maintained in accordance with cGMP and company standards for data integrity
● As the experienced SME, proactive drive the continuous improvement in the Lab support team by leading the taskforce to identify and implement new technologies to improve the compliance and efficiency in routine QC operations.
● Drive operational excellence through the implementation of QC scheduling, lean lab methology and continuous improvement initiatives.
● Support the integration of new technologies and digital tools to enhance lab efficiency and data management.
● Drive QC digitalization and AI technology implementation
Qualification and Experience 能力与经验
Education/Qualifications
● Bachelor’s Degree (Life Sciences, Pharmaceutical Sciences and Analytical Sciences is preferred) and above
● Strong knowledge of QC operation and maintenance with experience in aseptic processes preferred
Leadership Competencies
● Models Integrity
● Focus on value and customer
● Align for success
● Deliver results
● Learn for the future
Job Required Competencies
● 3 or more years of QC experience, MNC Bio-pharma preferred
● Sound knowledge of quality control procedures and legal standards.
● Sound knowledge of mathematics, data analysis, and statistical methods.
● Experience in strategic project of QC design, commissioning & qualification
● Experience in QC routine operation and QC systems(eg.LIMS, Empower)
● Experience in operation and maintenance of QC operational excellence (eg.Lean and 6 Sigma).
● Have the potential to think strategically and translate strategies into actionable plans, understands and apply agile ways of working
● Strong expertise in the management of laboratory computerized/electronic systems (e.g., LIMS, SAP), with an understanding of or experience with AI-driven tools and digital automation in lab operations.
Fluent in English (both written and spoken), with the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders across the global network.
我们是谁
打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。
让我们一起，构建更健康的未来。
罗氏提供平等的职业发展机会。