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
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.
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。