Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

QA Specialist

Your tasks and responsibilities

  • Keep consistency between registration dossier and local manufacturing documents including GMP and Non-GMP products. Responsible for review of renewal registration dossier and formula related document for new product from QA perspective.
  • 确保工厂生产相关文件与注册文件一致。负责从质量保证方面审核再注册文件及新产品处方等相关文件。
  • Review the new BOM or change BOM in SAP system, make sure all manufactured ingredients comply with that of registration documents.
  • 负责 SAP系统中新建BOM及修改BOM复核工作,确保实际生产配方与注册配方(注册标准)一致。
  • In charge of package material management, that to ensure all the package material compliance with Chinese law and regulation and HO requirement. 
  • 外印包材版本的控制及发放,保证现行包材符合中国当地法律法规要求及总部要求。
  • Archive and maintain all master file including the MI, PMP,BOM & specification.
  • 负责公司主文件的归档管理和维护包括生产母本批记录MI、生产工艺规程PMP、SAP系统中建立的 BOM、质量标准等。

Who you are

  • 负责协调确认和验证相关工作,确保符合全球验证标准。
  • Support change management, including DCI system, LCM and local change management, that to ensure  compliance with HO and Chinese Authority.
  • 负责协助变更管理,包括DCI、LCM及本地变更管理及协调,确保产品变更有依可循且符合总部及中国政府的要求。

 

Qualifications:

  • Education/Experience: Bachelor degree or above, majored in Chemistry, Pharmaceutics or related subjects,at least  5 years of QA experience in pharmaceutical industry.
  • 教育/经验:药学、化学或相关专业,本科及以上学历,至少5年制药行业QA相关工作经验。
  • Specific knowledge&skills: Familiar with GMP regulation in the pharmaceutical industry; Familiar with quality management system.
  • 专业知识:熟悉制药行业 GMP法规;熟悉质量管理体系。
  • Good skills in organization, presentation, analytical and problem-solving.
  • 良好的组织能力、表达能力、分析能力和解决问题的能力。
  • Good skills in office software using and good English skill in reading/writing/listening/translation.
  • 良好的计算机办公软件应用技能,良好的英语听读写译技能。

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Country: China
Location: ChengDu
Functional Area:
Entry Level: