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
Leadership & People Management
Build and retain an inclusive workforce and foster an environment where diversity of thought and perspective are valued.
Maintain an inclusive team that values diversity of thought.
Maintain strong partnerships with leaders to ensure alignment on strategic projects and daily operations.
Take the responsibility for department daily SHE management, implement site SHE procedure and program, and achieve site corporate /site SHE KPI. Promote SHE culture and improve employee safety behavior.
Manage performance and development team members to achieve organizational goals and employee personal and professional growth.
Support manager to build a strong pipeline of talent and robust succession plans for key positions.
Maintain a culture of continuous improvement and model lean leadership principles.
Maintain a culture of transparent, high performance, empowerment and innovation culture.
Technical
Engineering Project Support and Operation Readiness:
Participate in new facility design and construction, including but not limited to process design, equipment selection, URS review, FAT, SAT, IOPQ, APS etc. to contribute to project delivery.
As a key role, support to establish an effective operation system in alignment with the Roche’s standards, including manufacturing system, CCS strategy, people training and qualification system.
Lead to establish the procedures related to aseptic techniques, good aseptic practices on the shop floor, and other relevant processes for aseptic production execution.
Participate in CCS strategy implementation in operation to ensure a sustaining sterility assurance program setting up.
Support the filling manager to establish the site aseptic training program and implement it, ensure only qualified people perform GMP lots’ manufacturing.
Ensure team's competencies in performing the following tasks: e.g. vial washing, depyrogenating, filling and stoppering, crimping.
Participate in tech transfer, collaboration with other functions to ensure the success of new product manufacturing.
Perform other duties as assigned.
Routine Operation:
Ensure routine operation compliance with regulations, maintain sterile conditions, and achieve high-quality production standards.
Ensure total readiness of manufacturing suites, including housekeeping, machine, materials, documents and other resources to ensure product delivery in time and within budget.
Arrange the filling shifts in routine production, participate in operation as an aseptic SME and perform daily review of production batch record, deviation according to schedule.
Lead annual aseptic operators’ qualification, provide on-the-job training to support formalized technical and GMP training.
Oversee the daily operation, monitoring, and maintenance of filling equipment to ensure compliance with aseptic requirements.
Supervise aseptic operations during production and intervene promptly in case of abnormalities.
Participate in the response of regulator audit and global quality audit as SME during regulatory inspections and audits.
Raise deviation and involve the root cause investigation, including appropriate escalation where needed to ensure closure of deviation within the set timeline.
Raise change control and provide assessment.
Execute regular validation activities, such as APS.
Participate in Operational Excellence and Continuous Improvement initiatives.
Related IT system operations, such as SAP, MES, Veeva, Cornerstone.
Perform other duties as assigned.
Qualification and Experience
Education/Qualifications
College’s Degree (Pharmaceutical / Biological is preferred) and above.
Job Required Competencies
10 or more years’ operation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred.
3 or more years’ people management experience.
Experienced in strategic projects of Aseptic Filling facility including design, commissioning & qualification, Isolator filling line is preferred.
Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in the biological industry.
Fluent communications skills in English are 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。