Quality System Manager (职位编号：72346033)社

面议

南通市本科及以上7年及以上

发布时间：2023-09-06

职位描述

工作职责

To provide strategic and technical leadership for Qidong site in all quality system related matters and to ensure that all aspects of operational business comply with cGMP and regulatory requirements and Bayer CMS requirements.Responsibilities of Quality System cover documentation management, artworks, suppliers management (raw materials and packaging), GMP trainings, qualification and validation management, change control management, Self-inspection and health authority inspection management, compilation of technical files for registration dossiers, regulatory surveillance, KPI's reporting.Leading the site supplier management, including but not limited to supplier auditing, communication, QAAs, global database maintenance (AIDA, DaQS) etc. To ensure the supplier management system is well maintained at site level, and give quality recommendation for developing potential suppliers.Provide quality overview for qualification and validation activities to ensure comply with Bayer and local FDA requirements. Review and approve qualification and validation documents. Ensure change control is processed, reviewed and approved in a timely manner. Responsible for the change control review board meetings. Ensure that data integrity project is processed and completed within the time limits established. Ensure training program is maintained, an annual training plan is developed and approved, and executed as defined.Leading the site external/ authority auditing, including but not limited, FDA's on-site inspection , CAPA report submission etc. Active communicate with local authority for the on-site inspection and CAPA follow up.Leading site Global Quality policy (CMS) implementation, timely tack new effective CMS on the global website, coordinate and organize the site gap analysis , follow up actions. Ensure site quality system compliance with Bayer Global quality requirement.Leading site local regulation implementation, to ensure local regulation compliance , including but not limited to timely tack new effective CMS on the global website, coordinate and organize the site gap analysis , follow up actions. Ensure site quality system fully compliance with local regulation requirement.Leading site mock audit plan and report. And KPI report to Global, including Quarterly QMR, well maintained and follow up the QMR data, ensure site performance on the top level.Provide to the site Quality Head an overview of the situation in regards of his/ her activities with the level of details and frequency susceptible to enable the Site Quality Head to have a good understanding of the situation and to take the right decisions in due time.Propose and discuss potential improvements with his / her team and with Site Quality Head.Provide coaching to QMS team.Ultimately responsible for the responsible area HSE performance; SupportHSE activities followed internal & external regulations, procedures & SOPs.Other tasks send by Quality Head. 任职要求

Value added to the success of the company.Make sure quality system can provide constant reliable and compliance is very imported as site level.Education: Pharmaceutics or relevant bachelor degree or above (or intermediate professional and technical titles).Experience: 8 years or more working experience in pharmaceutical related area, minimum 5 year in Quality department.Good knowledge on Chinese & international GMP etc.Fluent English in written and in reading and spoken.Good communication skill.Leadership and Strong team spir********************

其他要求

招聘人数：1人
职能类别：

公司介绍

拜耳是一家全球化创新型企业，在生命科学领域的健康与营养方面具有核心竞争力。拜耳致力于以创新的产品帮助解决当今人类社会所面临的一些重大挑战。随着人类预期寿命不断延长，人口不断增长，拜耳通过专注于预防、缓解和治疗疾病的研发活动来改善人们的生活质量。与此同时，拜耳通过突破性创新引领农业未来，帮助农户、消费者得到健康、安全、可负担的食物，并且生产过程对社区、对环境友好。“拜耳：科技创造美好生活”是我们的使命，我们的目标是改善人们的生活质量。

拜耳于1863年创立，迄今已有150多年的历史，公司总部位于德国勒沃库森，全球拥有超过11万名员工。2018年财富世界500强排行榜中拜耳排名193位。早在1882年拜耳公司首次进入中国市场，至今已经超过130年。随着中国成为世界上增长最快的市场之一，拜耳也逐步加大了在这里的投入。拜耳中国总部位于上海，截至2018年12月底，拥有超过9,000名员工。2018年拜耳中国的销售额达到31.27亿欧元，折合人民币超过235亿元。

拜耳在中国有三大事业部：处方药、健康消费品和作物科学，并运营着多家工厂。早在1936年拜耳就开始在上海生产阿司匹林，目前本地生产在中国的销售额中所占比重越来越大。伴随着正在进行的一些重大投资项目，拜耳致力于成为在中国发展的主要引擎。

多年以来，拜耳作为人们心目中的理想雇主屡获殊荣，2018年我们荣膺中国杰出雇主、中国典范雇主、非凡雇主101-年度多元雇主、中国大学生喜爱雇主、最受***欢迎雇主等多个奖项。同时，拜耳也是提供均等机会的雇主。我们尊重并公平对待他人，不论其**、国籍、民族、文化、性别或性取向，我们重视并弘扬多元文化。“敢想|勇为”（Passion to innovate | Power to change）是拜耳的雇主品牌宣言，它概括了拜耳作为雇主的全部特点：其工作文化与公司对目前和未来员工的期望以及对他们的回报。

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