Goodrich Aerostructures Service (China)Co., Ltd<br>QA Librarian<br>Responsibilities<br><br>• Monitor the due date of technical data issued to the workshop and update the technical manuals<br>• Circulate relevant airworthiness directives, advisory circulars<br>• Liaise/coordinate with the Original Equipment Manufacture (OEM) liaison officer to obtain OEM technical data, update the specification and subscribe for technical information<br>• Compile the Engineering Approval Request /Designated Engineering Representative package <br>• Prepare monthly reports on revision status<br>• Send surveillance forms to suppliers and update the approved vendor listing <br>不限面议
|
天津天士力圣特制药有限公司<br>QA Specialist 质量保证专员<br>Position Summary 工作概述:
Under the leadership of Quality Assurance manager & aligned with company objectives, to establish & improve Quality Management System of Tasly-Sants plant, to ensure quality standards of products & services, by enforcing GMP implementation, implementing improvement plans, to meet & exceed customer needs in products & services.
在质量保证经理领导及符合公司目标情况下,建立并持续改进天士力-圣特公司的质量管理体系。通过坚强执行GMP体系,及实施改进计划,确保实现公司产品质量目标、满足并超越服务客户的需求。
Principal Accountabilities主要职责:
1. Set up quality management files, monitor the manufacturing documents & quality documents are revised timely, and implement pre-valuation, manage and maintain system documents, monitor documents execution.
起草质量管理文件,负责监督生产管理和质量管理文件的及时修订并进行预审核,负责文件体系的管理及维护, 监督文件的执行情况。
2. Review the batch record and other important records to ensure the review quality.
审核批记录和其它主要记录,并保证审核质量
3. Organize & join in annual internal quality auditing; inspect the improvement result.
组织并参加内部质量审核, 监督检查整改落实结果.
4. cooperate with external quality auditing & MAP tracing;
积极配合并参与外部质量审计工作,配合完成MAP的追踪。
5. Annual product review.
负责产品年度回顾。
6. Management & Investigation & follow-up of COC & non-conformance, and ensure close-up timely.
对变更和不符合进行管理、调查、跟踪,及时关闭。
7. Recalls handling, Quality related Customer Complaints investigation & follow-up.
召回处理、与客户投诉相关的质量问题的调查与跟踪。
8. Monitoring disposal of active/packaging/rejected materials.
监督活性物料、包装材料及不合格品的处理。
9. Supervise and ensure the manufacture process having been validation.
监督并确保生产过程在已验证的状态下进行。
10. Approve the printing package; assist in products and new products validation, testing and approval.
负责印字包材的批准,为产品及新产品验证、检测、批准放行提供支持。
11. Participate in quality audit of suppliers.
参与供应商质量审计。
12. Implementation of GMP & quality system and HES training of all manufacturing related functions. Responsible for IPC training and valuation.
实施所有与生产有关的部门人员进行GMP、质量体系、、安全环境方面的培训。负责IPC人员的培训与考核。
Job Requirements 任职要求:
Special requirement: Abundant knowledge on GMP, production & quality processes, quality system management, people management, current situation & trend of national & international pharmaceutical industry, Experience in QA.
特别要求:良好的GMP体系认识,了解生产工艺控制,熟悉质量体系管理、人员管理。了解目前的国内及国际制药行业的发展趋势。有QA工作经验。
Personality: Adhere to principles; Firmness in ensuring quality; Sense of quality first; Sharp eye on quality issues; Conscientious; emotionally stable; Honest & trustworthy; Proactive in pushing quality improvement initiatives.
个性素质:坚持工作原则、能够坚守质量信念、有强烈的质量观、对质量问题敏锐。负责、沉稳、诚实可信、主动推动质量改进。
Skills: Communication skills; Power of execution; Motivation & coaching skills.
个人技能:善于交流、有执行力度、激励及指导技能。
Educational Degree: Bachelor degree or above.
教育背景:具有学士及以上学历。
Major: Pharmacy; Pharm. Engineering; Biochemistry; Chemistry.
专业:药学、制药工程、生物化学、化学。
Language: Fluent English in writing and speaking.
语言技能:熟练的英语写作及口语交流能力。
Computer: Be proficient in using the computer software such as Word, Excel, PowerPoint, Internet, and Intranet etc.
计算机技能:熟练使用Word, Excel, PowerPoint, Internet, Intranet等办公软件。
Related Experience: 3 years working experiences in pharmaceutical industry.
工作经验:至少3年制药企业工作经验。
MNC Experience: 1 years experiences in MNC.
外企工作经验:1年以上跨国公司工作经验。不限
|