苏州相关职位： 化验分析员 质量部经理 技术支持工程师 包装技术员/Packaging Technician 二代测序生产经理 机械设计工程师/研发/有限元 注册主管（医疗器械） 市场总监 有机合成助理研究员 技术总监（口腔种植体）
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-09
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3-4年经验 -
本科 -
招1人 -
11-14 发布
职位描述
职位描述： 一、Job Summary职位概述:?Ensures RDSZ supplier (material/services) quality management system is implemented, maintained and further developed which is suitable and effective to satisfy regulatory requirements e.g., EN ISO 13485 /CFDA GMP/21 CFR 820 Regulations and Roche company policy and division standards.?Prevision of suppliers’ qualification progress (e.g., evaluate the new supplier criticality, request material specification, requirements and QAA) and supplier quality relevant master data and supplier release in MDG-S system.?Monitor the suppliers’ quality performance through defined KPIs and prevision of supplier audit SCAR follow-up and products and services non-conformity SCARs management if applicable as continuous improvements.?Provide support to supplier (material/services) quality issues; including technical subject matter expertise from quality perspective e.g., drive quality talk meeting/Supplier Corrective Action Request (SCAR) process. Initiate SCAR’s CAPA in system as inclusive data base for SCAR process related corrective and preventive actions.?Assist Services with implementation of Quality System, ensure services satisfy regulatory requirements e.g., EN ISO 13485 /CFDA GMP/21 CFR 820 Regulations and Roche company policy and division standards.二、Main Tasks & Responsibilities主要工作职责 :1.Develop and evaluate new suppliers1.1 Review material specification and services user requirements including support technical transfer from DOM in potentially local sourcing raw material; perform request materials/services criticality assessment.1.2Prepare supply quality related Quality Assurance Agreements based on suppliers’ criticalities.1.3Follow-up supplier audit results as audit SCARs in CAPA system.1.4Support suppliers release related tasks in MDG-S system.2.Assess suppliers and Continuous Improvement2.1 Assess suppliers’ performance through defined KPIs. Address any quality problems, drive quality talk meeting and supplier corrective action request process with suppliers, even for cause audit if applicable. Manage the CAPA system as inclusive data base for SCAR process related corrective andpreventive actions, verify the actions effectiveness for existing suppliers’ continuous improvement.2.2 Maintenance of approved suppliers list, suppliers’ Quality Assurance Agreements, supplier package quality system related documents.2.3 Connect with Global Supplier Auditing data base system owner, to maintain applicable supplier audit reports in place.3.Assist purchased services with implementation of Quality System3.1 Review services of quality system processes such as QAPs/SOPs, and document review/approval to satisfy regulatory requirements e.g., EN ISO 13485 /CFDA GMP/21 CFR 820 Regulations and Roche company policy and division standards. e.g., EN ISO 13485 /CFDA GMP/21 CFR 820 Regulations and Roche company policy and division standards.3.2 Provide support to services quality system issues, including technical subject matter expertise.4.Maintain and Further Development of suppliers’ management processes4.1 Maintenance and further development of specific processes for supplier’s lifecycle management tosatisfy regulatory requirements e.g., EN ISO 13485 /CFDA GMP/21 CFR 820 Regulations and Roche company policy and division standards.4.2 Deliver training of supplier quality management processes to ensure end users across functional areas understand them.4.3 Support MDG-S/SAP system operations for supplier quality management if applicable.三、Education 教育背景?University graduate (MSc) in one of the following fields: pharmacy, (bio-) chemistry, (molecular) biology, food and/or biotechnology;? Bachelor’s degree，preferred Master’s degree四、Experience 工作经验:?Experienced in the field quality management area(e.g., supplier quality related processes) (minimal 3 yrs.) Experienced in the field of development and implementation of SQ processes.(3-5 yrs.)五、Professional Competencies 专业能力?Thorough knowledge of regulatory and legal national and international requirements such as ISO 13485, IVDD, GMP, CFDA and knowledge of internal processes and systems, chemical, technical and medical basics of products, the medical devices.?Familiar with supplier development and evaluation at the industry level.?English in technical written and verbal communications.Preferred:?History of successful handling suppliers’ quality related issues and improvements?Experienced involving supplier auditing and improvement activities. Independent working style, experienced in organizational structures.?Good knowledge of English in technical written and verbal communications. 职能类别： 生物工程/生物制药 关键字： 供应商 质量 工程师
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公司信息
作为体外诊断的全球市场领导者，罗氏诊断的市场领导地位已遍及中国和亚太区。罗氏诊断在亚太区的发展已有40年的历史，员工超过4,000人，遍及该地区的15个国家。罗氏诊断致力于为全球的实验室和医院提供创新型检测和技术，从而帮助医疗专业人士为患者做出正确的医疗决策，让医疗支付者对可持续性医疗的未来投资正确的解决方案，最重要的是帮助人们提升自我健康管理能力，改善生活质量。 罗氏诊断计划在未来三年投资4.5亿瑞士法郎（约25亿人民币）在苏州工业园区建立一个新的诊断生产基地。新的生产基地将解决中国以及亚太地区对于诊断检测持续增长的需求。产品主要包括免疫和生化的检测产品。该生产基地计划至2018年内招聘超过400名员工。 苏州生产基地将是罗氏诊断全球第八大生产基地，也是亚太地区首个生产基地。到2018年，基地将全面投入运营。 罗氏诊断首席运营官: 罗兰·迪格曼 “能够在中国将罗氏诊断价值链扩展至生产环节令我们倍感振奋，罗氏致力于在中国和亚太区进行投资。新的生产基地将帮助我们更好地满足对于诊断产品日益上升的需求，并确保我们继续为中国和亚太地区人们的健康做出贡献。” 在工厂筹备的过程中，一个非常重要的目标就是吸引优秀人才、保证技术传递。更重要的是，在工厂全面投产后，我们需要一支成熟的团队来保证工厂能够在将来可持续发展。这对于个人发展而言，将是一个令人兴奋而富有挑战的机会。我们正在寻找具备相关经验和才能的你加入我们的团队，希望你愿意学习新的知识、能在国际化的环境中工作、并且很好的融入多元化的组织架构中。 每位员工都能够获得多样化的培训课程和不同的发展机会，而不仅限于海外培训、领导力发展计划等。 我们希望给员工创造最好的工作环境。欢迎你加入我们，让我们共同开启这个新的旅程，塑造新未来。
