南京招聘

Responsibilities:

1. Support activities related to product actions in the affiliate.

2. Assure key metrics are being met to ensure compliance and to drive continuous improvement.

3. Oversee coordination and investigation of key quality systems (ie. CAPA, product complaints) ensuring KPIs are being met.

4. Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.

5. Quality management of TPL including performance monitoring for key suppliers, QTA management and assessments.

6. Provide guidance and oversight for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.

7. Participate in training and education programs for various aspects of quality assurance.

8. Quality management of TPL including performance monitoring for key suppliers, QTA management and assessments Organize the audit and risk assessment of TPL quality management system

9. Provide guidance and oversight for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.

10. Responsible for QA release/ QA hold in system,

11. Provide guidance and oversight procedure of drug purchase, storage, maintenance, sales, rejection, transportation, etc. to comply with GSP and Abbvie procedure; Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.

12. Confirm nonconforming drugs, and overseeing for the nonconforming drugs handling process;

13. Investigate, handle and report drug quality complaints and quality event / non-conformance ;

14. Provide guidance and oversight for setting the quality control functions of computer system;

15. Provide guidance and oversight for the user role design of computer system and the establishment and updating master data of quality management;

16. Organize the investigation and assessment on the quality management system and service performance of distributors and transportation vendor;

Organize the examination on the transportation conditions and quality guarantee capability of the carrier authorized for transportation

Qualifications:

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, other scientific area.

• 3-4 years’ experience in quality assurance, operations, regulatory or relevant experience.

• Knowledge and familiarity with product, process, and both internal and external customer requirements and regulations.

• Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products.

• Strong influencing, motivational, interpersonal and relationship building skills at all levels.

• Excellent written and oral communication skills. Proficiency in English.

• Negotiation skills, effective collaboration and ability to anticipate needs and requirements.

Strong computer skills and knowledge of enterprise systems such as SolTraqs, Attache and Attache Pro.

关于艾伯维中国

艾伯维（纽约证交所:ABBV）是一家于2013年1月2日正式成立的全球研究型生物制药公司，从雅培公司拆分而来。 艾伯维将尖端生物科技与百年传承的专注、激情，以及专业技术和组织架构集于一身，凭借其专业技术、敬业的员工和独特的创新方式，旨在研发并推广先进治疗方法，解决世界范围内的一些疑难杂症。2013年，全新成立的艾伯维在全球范围内拥有近21,000名员工，产品销往170多个国家。

艾伯维已在中国正式注册成为一家外商独资的医药公司,并且于2013年6月1日完成与雅培中国的拆分。艾伯维中国的产品线涉及多个疾病领域，涵盖免疫学领域、抗病毒学领域、肾脏学领域以及麻醉学领域。同时，艾伯维与中国的医学界和政府部门紧密合作，共同开展覆盖丙肝、肿瘤、免疫学、神经科学、疼痛和妇科健康等领域的临床研究。

艾伯维中国介绍

中国总部    上海

研发中心    艾伯维中国研发中心——上海张江研发中心，落成于2009年3月，是艾伯维全球7个研发中心之一。作为临床前研究的一环，支持全球药品研发中心（GPRD）的药物研发，主要集中在免疫、疼痛、神经系统与肾病领域。

员工数    近500名

历史 艾伯维中国成立于2013年6月1日

企业评级

艾伯维被纳入标准普尔500红利经典指数（S&P 500 Dividend Aristocrat Index） ，纳入这一指数的标准是公司股票连续25年以上实现持续增长的现金分红。同时， 艾伯维也被纳入标准普尔高产红利经典指数（S&P High Yield Dividend Aristocrats Index） ，纳入这一指数的标准是连续20年以上实现持续增长的现金分红。

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