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
Quality and Technical Guidance
Support mobilisation of new sites from a quality, compliance perspective.
Lead or support the local implementation of global quality computerized projects (e.g., ASPIRE) by driving master data readiness, conducting end-to-end scenario test preparation and execution, SOP establishment/revision, and end-user knowledge sharing, and performing hypercare incident troubleshooting to ensure a smooth go-live
Lead the master data maintenance role in daily business operations on the quality computerized system(e.g. the Aspire project), including but not limited to master data management, resolving issues in a timely manner to keep the business running smoothly, maintenance of S/4 and BRH system execution procedures and BCP.
Identify, assess, and escalate potential computerized system quality module operation risks, and develop practical mitigation strategies and solutions to keep system running smoothly and meet business needs.
Serve as a key contact for computerized system quality modules and provide technical and process support to cross-functional business partners.
Collaborate to resolve computerized system quality modules issues, remove technical barriers, and ensure successful delivery of project/system objectives.
Provide ongoing operational and maintenance support for computerized system quality modules after go-live. Continuously assess the business suitability of system processes, gather user feedback, and lead process enhancements and continuous-improvement initiatives to ensure that the systems continue to support evolving business needs.
Perform other duties as assigned by the line manager.
Education/Qualifications
The candidate should have at least a Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline.
Good knowledge of all relevant GxP and Quality System requirements ( EU) for pharmaceutical and biotech, manufacturing and related activities.
Experience on regulatory inspections with Health Authorities and of interacting with representing the company to Health Authorities, their agents, or related entities.
Job Required Competencies
A minimum experience of 4 years in the pharmaceutical or biotechnology in quality assurance, GMP compliance, operations or validation, ideally in a multinational company.
Rich hands-on experience with tools like SAP, Veeva, and demonstrating strong stakeholder management, independent problem-solving, critical thinking abilities, and agile skills with flexibility to adapt to changes.
cGMP know-how and a thorough understanding of ICH guidelines, together with exposure to the international network.
Aseptic Filling experience is expected.
An ability to interact and communicate with all types of personalities in an effective and diplomatic manner
Good decision-making capability
Fluent communications skills in English 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。