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The Position

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 stakeholdersProvide 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 managementPromote members to complete tasks according to project goalsHave 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.
 

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.