北京招聘

The Position

Primary Purpose of Job (Job Summary)主要工作目标（岗位简介）
Ensure qualification, CSV (除QC) execution activities in SRPL compliance with relevant company policy, headquarter guideline and regulatory guideline.
确保上海罗氏的确认，CSV(except QC)执行活动符合有关公司政策、总部规范和法规要求。

Principle Roles & Responsibilities / Accountabilities 主要职责/责任
1. Team leadership Qualification: Leadership of Qualification Team. Train the team member, build up a professional team to execute Qualification. Liaison with other departments to facilitate Qualification Execution.
确认团队管理：领导确认团队， 为队员提供培训， 建立一支专业的确认团队。 与其他部门良好合作， 促进确认执行工作的顺利进行。
2. SME for Qualification: SME Present Qualification system of SRPL during inspections as Qualification SME.
确认执行代表人：在上海罗氏的审计中作为确认执行的代表人。
3. Master Plans: Be responsible for Qualification Master Plan initiation and maintenance. Perform scheduling and sourcing estimation for Projects
主计划维护：起草并且维护确认主计划。为项目建立时间表以及资源分配。
4. Maintain Qualification SOP: Be responsible for Qualification related SOPs initiation and maintenance.
维护确认相关SOP：起草并且维护确认相关的SOP。
5. Qualification Execution(initial project, periodic review): Supervise Testing and Execute Testing in Qualification.
确认执行(首次，回顾) ：监督或执行确认测试工作 。
6. CSV Execution: Supervise Testing and Execute Testing in CSV.
CSV 执行：监督或执行CSV测试工作。
7. Supplier Management: Be responsible for Supplier Management for Validation Department.
供应商管理：为验证部门管理供应商。
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
Qualification and Experience 能力与经验

Education/Qualifications教育程度/所获资格证书
Bachelor of Science Degree or above: Pharmacy, Chemistry, Biochemistry and equivalent
理学士及以上学位：药学、化学、生物化学及相关学科

Leadership Competencies领导者胜任力
N/A

Job Required Competencies岗位所需胜任力
10 years in pharmaceutical company, 10 years experience of qualification in pharmaceutical company
10年药厂工作年限，10年药厂确认经验
Professional knowledge of quality assurance, quality control or Pharma. production
质量保证，质量控制或制药生产专业知识
Project management skills and Leading team capability
项目管理能力及团队领导能力
Quality risk management or similiar experience
质量风险管理相关工作经验
Professional knowledge of quality assurance, quality control or Pharma. production
质量保证，质量控制或制药生产专业知识
Knowledge of GMP
GMP知识
Knowledge of Quality management
质量管理知识
Language skill: Good at English, listening, speaking, reading and writing.
语言技能: 具有良好的英语听说读写能力
PC skill: Winword, excel
电脑技能: Winword, excel

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Who we are
At Roche, 82,000 people across 150 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.

More Information related to This Position
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上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗病毒、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与政府、医疗机构以及非政府组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

更多罗氏中国信息，请登陆罗氏官网或访问罗氏招聘公众号。