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.
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.
- 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.
- 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
- Support change management, including DCI system, LCM and local change management, that to ensure compliance with HO and Chinese Authority.
- Education/Experience: Bachelor degree or above, majored in Chemistry, Pharmaceutics or related subjects,at least 5 years of QA experience in pharmaceutical industry.
- 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.
- Good skills in office software using and good English skill in reading/writing/listening/translation.
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.