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QA Operation Manager for DP

BioNTech

QA Operation Manager for DP

BioNTech

Nantong, JS, CN, 226000

·

On-site

·

Full-time

·

1d ago

岗位职责:

  • 全面负责制剂QA运营组的管理工作;
  • 负责带领制剂QA运营组执行制剂生产称量、配液、清洁与消毒、清场等现场监管;
  • 负责带领制剂QA运营组执行制剂生产管理与操作SOP的审核;
  • 负责带领制剂QA运营组执行制剂生产质量管理文件的优化与培训;
  • 负责带领制剂QA运营组执行制剂生产数据与批生产记录的审核;
  • 负责带领制剂QA运营组执行制剂生产偏差、变更、CAPA的审核,参与OOS事件调查;
  • 负责带领制剂QA运营组执行制剂产品的放行;
  • 负责带领制剂QA运营组执行制剂生产中不合格品的处理;
  • 协助带领制剂QA运营组执行制剂生产涉及的物料的放行与供应商的确认;
  • 协助带领制剂QA运营组执行原液/制剂产品技术转移;
  • 协助工厂项目注册申报工作;
  • 完成上级领导交付的其他工作。

任职要求:

  • 本科及以上学历,生物工程、生物技术及其他制药相关专业;
  • 工作满8年以上(硕士可放宽至5年以上);
  • 生物制药行业质量管理相关工作5年以上;
  • 英文CET-4以上,英语听说读写熟练。

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About BioNTech

BioNTech

BioNTech

Public

BioNTech 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

L2

L3

L4

L5

L6

Mid/L4

Intern

L2 · Data Scientist L2

0 reports

$53,767

total per year

Base

$21,507

Stock

$26,884

Bonus

$5,377

$37,637

$69,897

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