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罗氏促进多元化、公平性和包容性，代表我们所服务的社区。在全球范围内处理医疗保健问题时，多元化是成功的关键因素。我们认为，包容性是理解人们不同医疗保健需求的关键。我们共同拥抱个性，共同抱持对卓越护理的热情。加入罗氏，每个声音都会得到重视。
职位
1. Lab Establishment and Setup:
Lead the setup and validation of the new QC laboratory:
* Define the scope and requirements for lab infrastructure and layout.
* Select appropriate lab equipment and instruments, ensuring they meet the
necessary technical specifications and compliance standards.
* Arrange the installation and qualification of lab equipment including
IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance
Qualification).
Oversee laboratory layout design:
* Develop an efficient and compliant lab layout that adheres to GMP
requirements and supports optimized workflow.
* Ensure that lab workstations, storage areas, and other lab spaces are
designed to prevent cross-contamination and ensure safety.
Develop and implement standard operating procedures (SOPs):
* Create and document SOPs covering all aspects of lab operations, including
equipment use, maintenance, safety protocols, and testing procedures.
* Ensure that SOPs are regularly reviewed and updated in line with regulatory
changes and best practices.
2. GMP System Development:
Establish and maintain a robust GMP system:
* Develop and implement a comprehensive GMP framework that includes all
aspects of lab management and operations.
* Ensure that QC processes align with GMP requirements to guarantee product
quality and safety.
Develop and implement quality control procedures and protocols:
* Design and document detailed QC procedures for sample testing, handling,
and storage.
* Implement protocols for method validation, calibration, and testing
consistency.
Ensure proper documentation practices:
* Maintain accurate and complete records of all lab activities, including
test results, equipment logs, and compliance documentation.
* Establish data integrity practices to ensure that all records are reliable
and traceable.
3. Regulatory Compliance and Quality Assurance:
Ensure compliance with regulatory requirements:
* Ensure all lab operations comply with relevant regulatory standards (e.g.,
FDA, EMA, and other international guidelines).
* Stay updated on changes in regulations and industry standards to ensure
ongoing compliance.
Coordinate and support for audits and inspections:
* Prepare the lab for internal and external audits and inspections by
regulatory bodies.
* Collaborate with the qulity department to manage audit findings and
implement corrective actions.
Investigate and resolve quality-related issues:
* Perform root cause analysis for any deviations, out-of-specification
results, or laboratory incidents.
* Develop and implement corrective and preventive actions (CAPAs) to address
and prevent quality issues.
4. Collaboration and Communication:
Collaborate with cross-functional teams:
* Work closely with RA, Manufacturing, engineering and QA teams to support
the transfer and commercialization of biological drug products.
* Provide QC expertise to support product development, process optimization,
and troubleshooting.
* Communicate effectively with stakeholders
* Provide regular updates to internal and external stakeholders on lab
activities, project progress, and compliance status.
* Foster strong relationships with external partners and regulatory
authorities to facilitate cooperation and compliance.
5. Other business activities：
Understand and support day-to-day operations of the QC lab:
* Regularly review lab performance metrics and KPIs to identify areas for
improvement.
* Implement continuous improvement initiatives to enhance lab processes and
productivity.
* Leadership and project management
* Promote members to complete tasks according to project goals
* Have project node awareness and risk awareness, and actively communicate
with project-related personnel, such as project stakeholders and project
members.
* As the project manager, manage project conflicts, manage risks, and drive
project implementation.

我们是谁
在罗氏，来自100个国家的100，000名员工不断推动着健康医疗行业的进步。我们一同工作，使罗氏成为了世界领先的以研发为基础的健康医疗集团。我们的成功源于创新、求知和多元化，也源于我们把相互间的差异作为一种优势。为了革新医疗健康领域，罗氏设定了远大的计划，坚持学习和发展，并不断寻找与之志同道合的伙伴。
罗氏中国由制药和诊断两大业务领域组成，员工总数超过7000人。作为全球个体化医疗的领导者，罗氏制药和罗氏诊断均在中国建成了完整的价值产业链，包括研究、开发、生产、营销等环节。未来，上海将成为罗氏继巴塞尔和旧金山之后的第三大全球战略中心，而罗氏也将继续践行对中国的长期承诺，满足中国患者的未尽之需。
罗氏提供平等的职业发展机会。