Jobs
岗位职责：
- 建立车间偏差/变更/CAPA管理流程；
- 对车间相关人员进行偏差/变更起草的培训；
- 协助完成车间偏差/变更的起草，审核；
- 跟进车间偏差/变更/CAPA等执行，确保偏差/变更/CAPA能按时关闭；
- 定期对车间偏差/变更进行分析、总结和评价；
- 负责车间文件和记录的领用，发放，回收，归档和备份，保证文件的安全性，保密性和有效性；
- 跟踪车间文件签批进度，确保文件/记录在规定时间内完成修订及生效，以保证生产高效，有序进行；
- 领导安排的其它工作。
任职要求：
- 熟悉大分子生物制剂车间GMP要求；
- 8年以上药企业GMP文件或现场管理相关工作经，外企或国内头部生物药企业工作经验优先；
- 熟悉国内外GMP法律法规；
- 熟悉GMP质量体系与文件体系，偏差，变更的处理；
- 积极上进，学习能力强，执行力强，有大局观，工作效率高，善于沟通；
- 良好的英语听、说、读、写能力。
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About BioNTech
BioNTech
PublicBioNTech SE is a German multinational biotechnology company headquartered in Mainz that develops immunotherapies and vaccines, particularly for cancer and infectious diseases.
1,001-5,000
Employees
Mainz that develops immunotherapies
Headquarters
$21.7B
Valuation
Reviews
4.0
10 reviews
Work-life balance
2.5
Compensation
3.8
Culture
4.2
Career
3.5
Management
3.2
75%
Recommend to a friend
Pros
Innovative and cutting-edge projects
Great team and collaborative environment
Excellent benefits and flexible schedule
Cons
Long working hours and high workload
Fast-paced and high-pressure environment
Management and communication issues
Salary Ranges
70 data points
Mid/L4
Mid/L4 · Project Manager
3 reports
$122,537
total per year
Base
$106,811
Stock
$9,411
Bonus
$6,316
$88,589
$172,342
Interview experience
1 interviews
Difficulty
3.0
/ 5
Duration
14-28 weeks
Interview process
1
Application Review
2
HR Screen
3
Hiring Manager Interview
4
Panel Interview
5
Final Interview
6
Offer
Common questions
Behavioral/STAR
Technical Knowledge
Past Experience
Culture Fit
Problem Solving
News & Buzz
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6d ago