Quality Engineer 质量工程师
Shanghai / China / Full Time
Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2021 your step-up year. Come and join a growing team of highly motivated and exceptionally skilled professionals. CAI offers you control of your career, your professional development, your growth and path to success.
我们的客户正委托我们寻找一些令人激动的，有挑战性的和有回报的职位。为什么不让2021年成为你的成长年呢？来加入一个由积极性高、技术高超的专业人士组成的成长团队吧。CAI为您提供了职业生涯、职业发展、成长和成功之路。
Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organisation headquartered in the United States with offices in Ireland, Netherlands, Italy, Puerto Rico, Singapore, China, and Malaysia. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients. We work in the areas of quality compliance, regulatory affairs, automation, commissioning and qualification, validation, maintenance, and reliability, building commissioning, consulting, and information management systems.
CAI是一家快速发展的专业服务机构，总部设在美国，在爱尔兰、荷兰、意大利、波多黎各、新加坡、中国和马来西亚设有办事处。我们致力于制药、生物技术、医疗器械、营养和建筑调试行业，为客户提供行业最佳实践。我们的工作领域包括质量合规、监管事务、自动化、调试和鉴定、验证、维护和可靠性、建筑调试、咨询和信息管理系统。
Minimum Qualification
至少需要的资质
Degree in Science or Engineering or equivalent scientific discipline
理工科或同等学科学位
Minimum experience
至少需要的经验
3-5 years’ experience in Operational Quality Assurance with knowledge in Quality Management System and QA activities for multi-national companies and local top-class Bio/Pharmaceutical companies.
International experience would be desirable /advantageous.
Candidate must have good English skill for reading, writing, and speaking.
3-5年的操作质量保证经验，了解跨国公司和当地顶级生物/制药公司的质量管理体系和质量保证活动。
有国际经验者优先。
应聘者必须具备良好的英语读、写、说能力。
Role
角色
The Quality Engineer will provide quality oversight, support, and expertise in GMP related activities.
Provides knowledge and experience in Quality Systems and/or Operational Quality such as the following i.e., Deviation/ Change Control /Laboratory Investigations / Environmental Monitoring etc.
Support all quality and compliance requirements for and leading to commercial manufacturing.
Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solve complex problems and provide guidance and support for continuous improvement.
Offer a consultancy service to clients with less experience in Quality Systems and/or Operational Quality.
Understands and applies regulatory / compliance requirements to the role ensuring alignment and recommendation with current or upcoming regulatory and compliance changes.
Interprets client’s needs, assesses requirements, and identifies solutions to non-standard requests.
Ensure the highest Quality, Compliance and Safety standards
Works collaboratively to facilitate client and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.
质量工程师将在GMP相关活动中提供质量监督、支持和专业知识。
提供质量体系和/或操作质量方面的知识和经验，如偏差/变更控制/实验室调查/环境监测等。
支持所有的质量和合规要求，并导致商业制造。
利用知识改进质量体系和/或与客户的运营质量；解决复杂问题，为持续改进提供指导和支持。
为在质量体系和/或运营质量方面经验较少的客户提供咨询服务。
理解并应用监管/合规要求，确保与当前或即将发生的监管和合规变化保持一致并提出建议。
解释客户需求，评估需求，确定非标准需求的解决方案。
确保最高的质量、合规性和安全标准
协同工作，促进客户，确保质量体系相关主题和/或运营质量的一致性和最佳实践。
Location
工作地点
Work will mostly be executed remotely but travel may be required for mainland China and potentially throughout Asia.
工作主要是远程执行，但可能需要到中国大陆和整个亚洲出差。
In return for your skills and knowledge, CAI offers a wide range of benefits including:
作为对您技能和知识的回报，CAI提供了丰厚的福利待遇，包括：
· Health/Dental Insurance, 健康/牙科保险
· Life Insurance, 补充医疗保险
· Bonus scheme 奖金计划
· Paid time off带薪休假
· Continuing Professional Development and Education (internal and external)持续专业发展和教育（内部和外部）
· Opportunity to work abroad if desired.如果需要，提供出国工作的机会。
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