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上海市, 中国
Onsite
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.
Principle Roles & Responsibilities / Accountabilities
Engineering Project Support and Operation Readiness:
● Collaborate with cross-functional teams to implement GMP-related systems, processes, and workflows for the production department.
● Develop and implement GMP training programs tailored to production staff, aligned with corporate quality policies and regulatory requirements.
● Establish the deviation management and CAPA processes in manufacturing for handling non- conformances effectively and ensuring timely resolutions.
● Implement a robust change control process, ensuring GMP compliance and proper documentation of changes in the production environment.
● Participate in the preparation for facility qualification audits and regulatory inspections, ensuring that all systems and practices meet GMP standards.
● Lead consumable materials/service introduction and track the status to ensure to meet the manufacturing requirement.
● Support the development of GMP documentation including SOPs, validation protocols, and project-specific documentation for compliance.
● Perform other duties as assigned.
Routine Operation:
● Ensure routine operation in compliance with Roche’s GMP/SHE and regulation requirements.
● Serve as the primary interface between the production department and QA/Compliance teams for GMP-related matters.
● Manage ongoing GMP training programs, ensuring production personnel are regularly updated on GMP and compliance requirements.
● Oversee the timely identification, investigation, and resolution of deviations, ensuring proper execution of CAPAs to avoid recurrence.
● Evaluate and coordinate changes within the production department, ensuring proper implementation and documentation in line with regulatory requirements.
● Act as the production department’s primary liaison during internal and external audits, ensuring inspection readiness and addressing observations.
● Monitor GMP compliance in daily operations, identifying gaps and implementing corrective actions.
● Proactively identify areas for improvement in GMP operations, driving initiatives to enhance quality and productivity while maintaining compliance.
● Perform other duties as assigned.
Qualification and Experience
Education/Qualifications
● Bachelor’s Degree (Pharmaceutical / Biological is preferred) and above.
Job Required Competencies
● 5 or more years’ operation experience in GMP compliance roles in the injection pharmaceutical industry, MNC Bio-pharma preferred.
● Experienced in strategic projects of facility including design, commissioning & qualification is preferred.
● Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in the biological industry.
● Hands-on experience in deviation handling, CAPA management, change control, and audit preparation is required.
● Familiarity with compliance tools and systems for managing training, deviations, and CAPAs.
● Fluent communications skills in English is preferred and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.
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.