Quality Product Release Lead 产品放行经理 苏州

月薪：

该公司所有职位
  • 10年以上经验
  • 本科
  • 招1人
  • 02-02 发布

职位描述

Job Summary职位概述:Ensure batch release process in RDSZ meets the regulatory (ISO13485, China GMP and Annex 3 for IVD, FDA 21 CFR 820 etc.) requirements and the requirements from Divisional Quality Standard. Ensure the document management system in RDSZ meets the regulatory (ISO13485, China GMP, FDA 21 CFR 820 etc.) requirements and the requirements from Divisional Quality Standard.. The requirements are implemented effectively and elements of the identified areas in RDSZ quality management systems are continuously improved. Electronic Quality tools are used and maintained (e.g. Quality related functions in SAP, DiaDoc) and a trending of important Quality Metrics is carried out. Ensure the on site oversight through all material/product related processes.Main Tasks & Responsibilities主要工作职责 :1. Batch Record Review and Product Release –50%1.1 Business Process Owner for batch record review process, ensure all relevant interfaces with operation, QC within RDSZ and interface with corresponding QA organization outside of RDSZ is well integrated from both process and SAP perspective.1.2 Perform Batch Record Review and Product Release tasks following defined business process.1.3 Ensure the document management process is been setup and followed through whole site .14. Provide product release and document management related KPI trending in timely manner.2. Online Quality compliance oversight –20%2.1 Organize the periodic site tour to ensure QA oversight in operation processes(including QC and warehouse) and environment.2.2 Perform the compliance review for all identified product manufacturing, testing and storage related procedures2.3 Drive shop floor quality mainset continuously improvement through daily business3 Employee Leadership –30%Initial training, leading and development of directly subordinated employees as per “Performance Management” and “Succession and Talent Management” procedures in regards to functional requirements and skills. Conduction one-on-one, assessment of training needs, salary adjustments, review of tasks as well as assignments and reassessment of further training needs with respect to skills, products, processes and regulatory requirements.Education 教育背景-- University graduate (MSc) in one of the following fields: pharmacy, (bio-)chemistry, (molecular)biology, food and/or biotechnologyPreferred 优先考虑Master degree of Biology or bio pharmacist will be preferredQualification & Certification资质证书-- Detailed understanding of the common processes in production and R&D as well as general business practices within the regulated field of diagnostics and/or pharmaceuticals.Preferred 优先考虑:Detailed understanding of bio product manufacturing or vaccine manufacturing process will be preferredExperience 工作经验:-- Well experienced in the field of development and implementation of QM / QA processes (10-15 yrs.)-- Long-term experience(above 5 years) and proven skills in leading employees via successful leadership strategies, implementation of processes and structures, including motivation and individual development of employees together with the implementation of restructuring processesPreferred 优先考虑:Well experienced in product development and process validation(3-5 years) , have deep understanding of product FMEA and risk assessment philosophy will be preferredProfessional Competencies专业能力：-- Familiar with relevant regulatory statutes and industry standards, such as ISO 13485, IVDD, GMP, CFDA Experienced with the principles and system processes / tools within the QA/QM field-- Experienced in dealing with all level of authorities including China FDA officers, TUV auditors, Korea FDA officers, etc.-- Experienced in analysis of QA/QM processes, particularly with respect to compliance, efficiency and effectiveness-- Professional QM-auditor with specific certification / degree-- Independent working style, well-experienced in organizational structures-- Proficient in communicating and presenting topics with business clientele-- Knowledgeable in statistics-- Experience with development, implementation and change processes-- Skilled in thinking interdisciplinary; creating confident and open relationships within all organizational levels, specifically within matrix organizations-- Proficient language skills (written and spoken) in Chinese and English Competent with routine application of MS Office, SAP and other common office software, incl. databasesPreferred 优先考虑:Prefer to have strong background in ;-- Familiar with relevant regulatory statutes and industry standards, such as ISO 13485, IVDD, GMP, CFDA Experienced with the principles and system processes / tools within the QA/QM field-- Experienced in dealing with all level of authorities including China FDA officers, TUV auditors, Korea FDA officers, etc.-- Deep understanding in process validation and cleaning validation 职能类别： 生物工程/生物制药 关键字： 产品 放行 质量

联系方式

旺墩路188号

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。

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