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