Johnson & Johnson Careers

Senior Compliance Supervisor

Xi'an, China
Compliance


Job Description

Requisition ID: 1905763730W

在认证部经理领导,遵循SFDA,欧盟法规,和J&J政策,结合公司目标,完成认证部相关的工作, 主要包括管理监督外部制造商和承包商以确保全面符合GMP,管理变更流程等。

Guided by SFDA and EU regulation, J&J policy and aligned with company objectives, led by Compliance Department Manager, to complete related work including CoC management, to ensure the External Manufacturer and contractor being full compliance with GMP.

 
主要职责:

1. 负责管理变更流程, 确保变更的评估,批准按程序执行。确保变更程序符合法规和集团要求;Responsible for change control process, ensure the execution of assessment and approval of CoC. And ensure CoC procedure is compliant with requirement of regulation and global standard;
2. 负责 Indirect 供应商的管理,确保符合集团要求;Responsible for Indirect supplier management, ensure the compliant with global standard


3. 与EM Q合作管理外部制造商和承包商,必要时在最新规章和J&J政策基础上,起草与商榷质量协议;

Work with EM Q together to manage External Manufacturer and contractor, draft and negotiate the Quality Agreement based on newest regulations and J&J policy if necessary;


4. 支持内审和外审(包括药监审计),与相关政府部门建立良好伙伴关系;

Support internal audit and external audit (including Health Authority Inspection). Maintain the good relationship with healthy authority agencies;


5. 与相关工厂部门协作持续提高工厂的GMP 意识和质量文化;

Continue enhancing GMP awareness and quality culture by collaborating with cross functions teams of the site;

  1. 积极参与SHE培训、实施SHE政策方案;
Actively participate in SHE training, implementing the SHE policy & guidelines; 其他上级领导分配的任务。 Other assigned tasks from line managers.


Qualifications
  1. 制药学、化学、生物化学、制药工程专业本科及以上学历Bachelor degree or above in pharmaceutical, chemical, biochemical, pharmaceutical engineering.
  2. 5年以上制药行业工作经验,3年以上跨国公司工作经验5 years working experiences in pharmaceutical industry, more than 3 years working experiences in MNC
  3. 中英文听说读写流利 good command of both Chinese & English
  4. 熟悉医药生产,及相关的设备设施 Familiar with pharmaceutical manufacturing, equipment, facility
  5. 丰富的中国GMP,欧盟GMP及相关法律法规知识 Solid knowledge of China GMP, EU GMP and related regulations
  6. 质量保证及质量控制经验丰富 Rich experience on Quality Assurance and Quality Control   

Primary Location
China-Shaanxi-Xi'an-
Organization
Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function
Compliance
Requisition ID
1905763730W