北京招聘

Position Overview
 Provide end to end support to Complaint Vigilance (CV) processes primarily in Greater China through implementation of product complaint management processes, monitoring of complaints and drive improvements. This may include, but is not limited to, approval, investigation, trending and issues resolution. Support APAC CV Lead for review of complaint processes such as Complaint Vigilance Review Board, Metric, CAPA Review Board, Investigation and Audit management. The position holder must have the ability to assist with various global and regional projects within the department, communicate effectively with all levels of management.
 
Key Responsibilities 
The position holder:
 
Processes product quality complaint, reviews and approves complaint in accordance with Standard Operating Procedures using the Complaints Management System. This may include, but is not limited to, review complaint case to verify customer verbatim, lot number, subject coding, trend analysis, malfunction coding, and complaint closure as applicable. 
 Collaborates with Call Centers, Medical Safety, Marketing, Internal affiliates, External sites, and other business partners to ensure the integrity, consistency, compliance, and alignment of the end-to-end complaint vigilance process.
 Assists with developing training presentations for complaint vigilance process and systems and creation and updates of controlled documents. 
 Analyzes data, prepare trend reports, complaints metric and present to management and business partners as needed. 
 Provides periodic training and support to triage and investigation team in execution of the complaint and processes to ensure compliance to the complaint management process.
 

Qualification and Experience required: Master’s/ Bachelor’s degree in Pharmacy, Science discipline with a minimum of 7+ years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical, medical devices or other related or highly regulated industry. 
 Technical Competencies:  ？ Demonstrates knowledge and expertise in quality system global regulatory requirements, including ICH Q10.  ？ Demonstrates understanding of medical/ product quality complaints and associated GMP compliance requirements. Able to understand/discern safety, business (legal), and compliance risks related to complaints and in achieving performance objectives / indicators. ？ Ability to develop and implement simple, yet effective quality systems and metrics  ？ Ability to evaluate quality system elements and recommend improvements to meet regulatory requirements.  ？ Demonstrates understanding of basic manufacturing processes and associated GMP compliance requirements  ？ Strong knowledge of GMP Regulations, China FDA and local regulatory guidelines, ICH and ISO guidelines including but not limited to:, ICH Q7, Q8 and Q9, and ISO 10002, 9001, 13485, and 14971. 
 Requirements:  ？ Demonstrated knowledge and expertise in quality processes and regulatory requirements.  ？ Experience working in an FDA regulated environment.  ？ Experience supporting manufacturing, packaging, and development operations. 
 
？ Experience supporting many/all aspects of the complaint vigilance life cycle for pharmaceutical, device, and /or cosmetic products. Device and pharmaceutical strongly preferred.  ？ Experience with one or more technologies supporting complaint handling. PQMS or similar system preferred.  ？ Experience in the creation, update, and management of complaint files from complaint identification through closure.  ？ Expertise with root cause analysis techniques including but not limited to: Brainstorming, data analysis and collection tools, 5 Whys, Fishbone (Cause and Effect), FMEA ？ Experience with tools and techniques supporting qualitative risk analysis including but not limited to: Probability and impact assessment (likelihood of recurrence and potential effect), probability and impact matrix (risk ratings, rating rules), and risk categorization (by root causes, other qualifiers).  ？ Experience with systems and tools supporting analysis and reporting. 
 
 
Skill ability: ？ Decision-making and problem solving: Deals with issues using deductive reasoning, critical analysis skills and systematic approaches.  ？ Innovation/creativity: resourcefulness, inventiveness, or creativity is normally required to devise methods, procedures, products, scientific applications etc. Deliver value-added business results through execution and controls.  ？ Possesses strong organization and project management skills supporting the ability to prioritize and manage workload and meet performance expectations. Own critical thinking, leadership skills. ？ Excellent communications (verbal, written and listening) and collaboration skills – demonstrated through work, projects, presentations, accurate information gathering, and productive discussions/results ？ Professional skills in the English language, both in spoken and written. 
 

强生是全球具综合性、业务分布范围广的医疗保健企业，业务涉及消费品、制药、医疗器材三大领域，1985年在华创立了***家合资企业。强生遵循企业信条的价值观，致力于践行“关爱全世界,关注每个人”的健康愿景，以领先的科技研发创造创新的理念、产品和服务，为改善人类健康和福祉而不懈努力。每天，强生遍布世界各地的员工，与他们的合作方一起，为全球消费者和病患带来更健康、更快乐、更长寿的生活。
强生于1985年在华创立了***家合资企业。 多年来，强生不断发挥行业领军作用，以创新、高质量的产品和服务，为中国亿万家庭带来健康。如今，强生在中国的业务涉及消费品、制药、医疗器材三大领域，在北京、上海、广州、苏州、西安等90多个城市，拥有员工总数近10,000人。强生在西安高新技术产业开发区投资兴建先进的大型生产基地，以更好地服务中国和亚太地区其他国家。
强生是***在中国成功实现“端到端”研发模式的跨国企业；并通过实现从早期研发到临床应用，致力于加速中国创新产品的研发，促进中国创新型经济的发展。强生的三大业务领域在中国均设有研发机构, 并在上海建立了强生亚太创新中心，将源自于中国和亚太区域的创新成果推向国际市场。
该创新中心是强生深化外部合作战略的主要窗口。强生将密切与创新企业、学术和科研机构，以及优秀人才的合作，通过提供资金、专业知识和技术，共同将雏形创新转化为医学临床应用的成果，强生并在中国建立全球肺癌研究中心，以满足中国及国际市场的需求，造福病患。
强生心系中国的发展和进步，致力于成为优秀的企业公民。强生积极参与各类重大活动，助力中国的社会经济发展， 并荣幸的成为2008年北京奥运会及残奥会和2010年上海世博会美国馆的全球合作伙伴。
为加强对中国市场的承诺，强生于近期部署了中国发展新战略。强生将融汇全球的资源、凝聚在华的核心业务能力，更加稳健的迈开公司积极创新、完美执行和锐意领先的步伐，为中国创造更多价值。
强生多次荣获《巴伦周刊》“全球最受尊敬企业”的荣誉，充分体现了强生始终以实际行动改善人类健康福祉的不变理念。
2017年，强生连续第33年入选美国《财富》杂志发布的全球最受赞赏企业排行榜，位列总榜第13名，居全球制药行业榜首。