Senior Compliance Engineer

内外部GMP 审计
External/Internal GMP Inspection
- 制定年度工厂自检计划
Prepare annual plant internal audit plan
- 作为自检组长，执行内审
Carry out internal audit as lead auditor
- 制定内审员培训计划，管理内审员资质
Prepare training plan of internal auditor and manage internal auditor certification process
- 协调外部GMP/内部GQA 审计
Coordinate external GMP/GQA inspections
- 协调内外部审计CAPA 的制定，审核并跟进其完成
Coordinate CAPA creation, review and follow-up CAPA implementation.

GMP 法规符合性事务
Compliance affairs
- 准备和递交生产许可证认证、已上市变更备案等资料Prepare and
submit the documents for DML certification and post approval variation filing etc.

- 维护GMP 法规相关证件，并确保有效
Maintain GMP relevant license and ensure validity.
- 日常官方机构所需文件\数据的准备和递交工作
Document and data preparation and submission to authorities
- 支持药品注册事务，协调并执行相关的法规注册文件的审核
Support regulatory affairs, and coordinate and carry out the review of registration dossier within Taizhou site
- 负责法规文件的评估和审核
Responsible for regulation assessment and review
- 和外部法规机构保持良好沟通
Keep good communication with authorities
合规文件记录审核
Review Compliance activities
支持合规经理审核合规相关标准操作流程/表格、培训材料等。
Assist the team leader to review compliance SOPs/Forms, training
records etc.,.

工作要求Job Requirement

药学相关专业本科或以上学历
Pharmaceutical or relevant bachelor or above
- 8 年或以上制药质量管理经验，良好GMP 知识
Eight years plus working experience in
pharmaceutical industry, Good GMP knowledge.
- 良好英语说写及计算机能力
Good oral and written English, good computer skill
- 良好的沟通技巧，强烈的质量意识和服务意识
Good communication skills, strong quality minds and
strong service minds

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.