北京招聘

JOB DESCRIPTION

 

POSITION SUMMARY:

This position will support BQ Quality Leader to ensure quality of, and meeting with the applicable requirements for, the products that Xian Janssen marketed products.

He/She has supporting role to ensure compliance with the local laws/regulations and Johnson & Johnson applicable requirements; implementation and maintenance of Quality system and processes as are described in the Business Quality Manual and continuous improvement.

 

PRINCIPAL RESPONSIBILITIES:

Main responsibilities will include, but are not limited to:

1. Support to maintenance and implementation of Quality System as are described in the Business Quality Manual, continuous improvement of Quality System using quality system performance information, in conjunction with information from periodic internal audits, deviation management, CAPA management etc.

2. Ensure that Xi’an Janssen products, components, labeling meet the local regulation requirements;

3. Audit Readiness

• Support preparation, execution, and follow up for external inspections; JJRC audit and internal audits

1. Ensure all related events and deviations of products and critical systems are timely handled, documented, investigated for route cause and assessed for its impact on product quality and safety; Ensure appropriate corrections and preventive actions are taken to mitigate the effect of an event/deviation as well as to prevent recurrence in the future.

2. Support activities to ensure compliance with internal and external quality complaint management; collaborate with internal partners on complaint management;

3. Escalation of Quality and Regulatory Compliance Issues.

    

QUALIFICATIONS:

1. Bachelor of Science (BSc) degree in a life science, natural science or business is required.

2. At least 5 years of experience in a GxP regulated discipline.

3. Experience in and/or knowledge of risk management in a regulated industry is required.

4. Understanding of Pharmaceutical products development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;

5. Up-to-date knowledge of relevant pharmaceutical legislation and GxP;

6. Fluency in English is required

 

公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国***的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。

本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。 此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。

目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。

2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。