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Associate Director, QA (Ref: 4014BR)

宜曼达贸易(上海)有限公司 2016-12-05发布 2017-07-11截止
  • 学历要求: 不限
  • 外语要求: 不限
  • 年龄要求: 不限
  • 专业要求: 不限
  • 工作年限: 不限
  • 月薪范围: 面议
  • 职位性质: 全职
  • 工作地点: 上海市黄浦区
  • 职称要求: 不限
  • 招聘人数: 1人

职位描述

All About Us
Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives.

We’re an established company with a track record of phenomenal growth. Our revenue grew from $10 million in 2002 to approximately $2.2 billion in 2015. Our growth isn’t just revenue, we’ve been hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies list three years running, including #1 in 2014. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you – imagine the possibilities.

Position Summary:

This position is responsible for Quality activities that measure, monitor, and improve Illumina’s compliance with the Quality System Regulations, Illumina Quality policies, cFDA/FDA regulations and ISO standards as well as Illumina product quality for current operation and compliance objectives.

Tasks and Responsibilities:

•Supports the distribution warehouse with focus on compliance with applicable China GMP Quality Management System, Quality System Regulations (QSR), ISO 13485 requirements and GDP Good Distribution Practice
•Ensures adequate control of nonconforming material.
•Manage investigations, disposition and CAPA processes.
•Develop, review and approve Quality System documents (e.g., Standard Operating Procedures, Forms, Specifications, Validations, etc.) to ensure compliance with applicable regulations (e.g., GMP, GDP, QSR, ISO, etc.)
•Monitor and analyze key metrics and drive improvements to distribution processes.
•Facilitate the training program required for Illumina customer facing personnel.
•Ensure that records are complete, accurate and timely.
•Support development and executions of process verification and validation plans.
•Review and approve planned and unplanned changes/deviations.
•Collaborate with the Global Quality team to oversee, support, facilitate and/or drive the following areas:-◦Change management activities
◦Complaints, recall, field correctives
◦Compliance Audits, inspections
◦Suppliers / Service providers management
◦Quality Management Review
•Other such duties that may be determined by Management.
•Partner/collaborate with Illumina’s Regulatory Affairs to assure the successful approval and ongoing compliance with the APAC region requirements.
•Partner/collaborate with Illumina’s Commercial and Legal organizations to support the Quality Assurance elements of commercial agreements, channel partners, and quality agreements with customers and suppliers.
•Develop the Quality/Regulatory strategic plans required to enable Illumina’s China NGS market for both RUO and Clinical products.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

All About You
Requirements:

•Experience in Good Distribution Practice (GDP)
•Experience in supporting logistics/distribution environment
•Experience in cold storage and shipping validation highly desired.
•Six Sigma/Lean training;
•Experience in CAPA and Kaizen;
•Project management certification
•Working for a Medical Device or Medical Diagnostics company;
•ISO 13485 and ISO 9001 experience
•China FDA regulatory experience

Competencies:

•Ability to apply experience in meeting requirement of China Good Manufacturing Practice and ISO 13485 Standard.
•Experience in applying appropriate quality tools.
•Effective failure investigation, technical report writing, data mining, trend analysis, statistical analysis.
•Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools.
•May have experience with electronic production life (PLM), enterprise resource planning tools (SAP) and etc. Experience with SAP PLM preferred.
•May have experience with statistical analysis packages, eg, JMP, minitab.
•Must be detailed oriented, well organized and able to work independently and in teams.
•Preferred proficiency in spoken and written english communication.

Educational:

•Bachelor’s Degree in Engineering or Biological/Life Sciences
•Master’s Degree preferred
•More than 5 12 years of working experience in a regulated quality environment
该单位 HR 近两周的应聘简历处理率: 20%

联系人: 宜曼达人事部

地    址:中国上海市淮海中路333号瑞安广场2210室

All About Us

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.

lllumina has experienced phenomenal growth from $10 million in revenues in 2002 to approximately $1.9 billion in 2014. Forbes named Illumina #1 on the 2009 list of 25 Fastest-Growing Technology Companies in the United States, the second time over a three year period that Forbes ranked Illumina #1 on its list of rapidly growing technology companies. Illumina was also named #1 smartest company in the world as part of MIT’s 2014 Technology Review. As of December 2014, the company had a $26 billion market capitalization. ...详情

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