上海招聘

体外诊断试剂质量经理/总监

岗位职责：

1．负责按照《体外诊断试剂质量体系考核实施规定》、cGMP和ISO13485建立质量管理体系；

2．负责公司质量管理体系文件起草；

3．负责体外诊断试剂生产全过程的质量管理和监控，对公司产品的质量负全部责任；

4．负责公司质量管理体系认证，制定计划并主持通过体系考核；

5．实施、管理公司质量管理体系的运营；

6．协助完成洁净厂房的设计、安装工作；

7．负责公司计量仪器的送检计划制定及执行；

8．公司安排的其他任务。

岗位要求：

1. 生物、化学、制药相关专业，本科及以上学历，具有3年以上体外诊断试剂行业质量保证管理经验；
2. 熟悉体外诊断试剂生产质量管理规范的要求，成功主持过体外诊断核酸试剂质量体系考核；

3．熟悉体外诊断试剂行业行业相关法律、法规，熟悉GMP及相关法规和标准，了解ISO9001、CE、ISO13485等相关的标准，能进行ISO13485、质量管理等知识培训；
4. 熟悉实时荧光PCR原理，能及时发现生产过程中出现的异常情况，并能结合生产过程的实际情况提出可能的原因，并协助生产、技术问题的解决；
4. 具有执业药师或/和13485内审员资格证书；
8．强烈的事业心和责任感，诚实正直； 具有团队精神；

9．熟练使用各种办公软件，良好英语水平。

QA Director -
Posted Position Title
Role Summary/PurposeThe Quality Assurance Director – Quality Management System (QMS) drives the Quality and Compliance activities for the Quality Management Review (QMR) process, Quality Management Systems (QMS) implementation and quality data review and analytics across GE Healthcare (GEHC) business.
Essential Responsibilities?Translates Global Quality Assurance vision into goals, objectives strategies and measures for the organization
?Leads the Global QMS function for GEHC; will directly manage employees as well as coaching, teaching and developing QA professionals at all levels of the organization
?Leads and executs the QMR process
?Assures communication, document management and training for the QMS organization
?Drives region/site compliance accountability for QMS implementation and QMR execution
?Maintains procedures and policies, requirement flow downs from applicable standards, regulations and directives as applicable
?Creates transparency, visibility and monitoring of common quality metrics in the QA organization, across cultures and region/sites with automated dashboards
?Conducts analysis of metrics data to provide comparison of prior periods, industry performance and provides insight/recommendations for strategic initiatives for improvement.
?Assure CAPA process is functioning to support on-time, audit ready and effective solutions to significant events and trends.
Qualifications/Requirements1.Bachelor’s degree and at least 5 years Quality Assurance and/or Regulatory Affairs experience in the medical device or pharmaceutical industry
2.At least 5 years experience managing/supervising others
3.Demonstrated knowledge of Quality systems (demonstrated experience with ISO, GMP., FDA and/or other key regulatory bodies)
4.Knowledge of/exposure to manufacturing, engineering or product development processes
5.Ability to communicate effectively in English
6.Prior experience using word processing, spreadsheet, and presentation software
Additional Eligibility QualificationsGE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics1.Demonstrated experience with applying Quality tools
2.Experience interfacing with FDA and global regulatory agencies and ability to interface with central governmental regulators
3.Strong business acumen; uses financial analysis to make important business decisions and understand key financial metrics, can articulate the company’s business vision and key business objectives, understands business trends and cycles
4.Able to respond/react with appropriate urgency/professionalism and make decisions under pressure/stress
5.Ability to comprehend and communicate/translate key regulatory body requirements/expectations and ability to read, analyze and interpret scientific and technical journals, financial reports and legal documents.
6.Ability to respond to escalated inquiries/complaints form customers/regulatory bodies and members of the business community
7.Ability to detect trends/shifts in requirements and align/shift internal organization priorities and actions accordingly
8.Prior experience creating process workflows for data collection.
9.Demonstrated ability to lead teams across regions/cultures/sites.
10.Thorough understanding of Operations and Quality, particularly how a manufacturing site and/or regions, sales, and service sites function.
11.Ability to help design and implement IT solutions related to compliance and process improvement.

上海普洛麦格(Shanghai Promega)生物产品有限公司是美国普洛麦格公司全资拥有的外商独资企业。公司主要生产和销售细胞生物类、生物化学类、生物试剂盒类、临床诊断试剂盒类产品。公司依托美国普洛麦格总部的研发和技术优势，配备先进的生产设备和训练有素的技术骨干，确保公司的产品在全球市场上具有质量和成本优势，满足公司日益扩大的生产规模之需求。公司的战略目标是成为世界级的蛋白质产品、核酸标记物和分子生物学试剂盒的生产基地。
上海普洛麦格(Shanghai Promega)公司自一九九二年六月成立以来，历年都被认定为高新技术企业和 先进技术企业。公司自一九九七年起全面实行质量体系管理并于二〇〇〇年顺利通过了上海质量体系审核中心的认证，取得了ISO9001的质量体系认证证书，并连续十二年复审通过。二〇一三年又顺利通过了英国BSI ISO 9001:2008和ISO 13485:2003 质量体系认证，取得质量体系认证证书。二〇一四年又获得了上海市食品药品监督管理局颁发的医疗器械生产企业许可证。