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.

Jr. QA Specialist

Your tasks and responsibilities

 1. Implement the material and products release  procedures.
 - Follow the release procedures to complete the review and release of
 raw materials, excipients and packaging materials.
 - Follow the release procedures to review the batch manufacturing
 records and testing records for finished goods(FGs), and provide review
 summary report for QP to release the FGs.
 - Carry on routine monitoring on production, warehouse and engineering
 areas.
 - Ensure the release review is completed timely to support the product
 supply.
 2. Responsible for working together with RA to complete the
 registration activities for both domestic and overseas products:
 preparing or revising the registration technical documents according to
 RA request, tracking the submission approval status, managing the
 technical documents provided to RA.
 3. Responsible for PTCs and customer consultations of Bayer products.
 The PTCs are handled and investigated timely. According to the
 procedures, complete the related processing in the complaint system.
 CAPAs following up are documented.
 4. Responsible for rejected materials management.
 5. Responsible for completing the annual product review for the
 assigned products as per the instructions from Quality Head or Release
 Manager.
 6. Complete the other tasks assigned by Quality Unit Head and Release
 Manager.
 1. 实施物料和产品放行程序
 -按照放行程序完成原辅料、包装材料的审核和放行。
 -按照放行程序完成成品的审核,并提供审核报告给质量受权人进行放行决定。
 -负责对生产、仓库和公用系统进行日常监督
 -及时完成放行审核以确保产品供应
 2. 配合RA完成国内外产品的注册:
 -按照RA的要求完成注册技术资料的准备和更新
 -跟进注册资料提交批准的进展
 -管理注册技术资料
 3. 负责及时调查和处理产品技术投诉和咨询并回复消费者。按照流程完成投诉的系统录入、调查关闭并跟进CAPA的实施。
 4. 负责不合格物料的处理。
 5. 负责完成年度产品质量回顾。
 6. 完成质量部经理和放行经理安排的其他工作。
 Position: Skills,...
• Bachelor or above in chemistry/pharmacy or other related areas
 • 5 years' experience in Pharmaceutical manufacturing and quality.
 • Superior knowledge of cGMPs and related guidance, quality management
 principles, pharmaceutical/medicinal product manufacturing.
 • Hands on mentality in execution of sustainable Quality system
 implementation
 • Excellent organization and communication skills esp. the ability to
 work with cross functional teams
 • Fluent in Mandarin (orally and writing), good communication skills in
 English (oral and writing)
 化学、制药或相关专业,本科及以上学历;
 具备生产及质量管理的相关经验,熟悉GMP及相关法规要求,具备质量管理流程、药品生产相关知识;
 5年药品生产及质量相关的工作经验;
 有意识实施可持续的质量体系;
 良好的英语能力;
 良好的沟通技巧和团队精神。

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: KunMing
Functional Area:
Entry Level: