职位描述
GMP认证FDA认证NMPA认证
1.Conduct GMP Audits
Serve as lead auditor to perform on-site GMP compliance audits mainly to API, excipients and packaging materials manufacturing sites.
Audit scope includes quality systems, production, laboratory operations, facilities & equipment, materials management, and data integrity.
Accurately identify non-conformances and potential compliance risks.
2.Reporting and Follow-up
Prepare professional, clear, and objective audit reports in English, documenting findings and conducting risk assessments.
Track and evaluate the appropriateness and effectiveness of clients’ corrective and preventive action (CAPA) plans.
3.Knowledge Management & Internal Coordination
Maintain effective communication with the audit operations team and other collaborating departments.
Participate in internal auditor training programs and contribute to the update and maintenance of the knowledge base.
Serve as lead auditor to perform on-site GMP compliance audits mainly to API, excipients and packaging materials manufacturing sites.
Audit scope includes quality systems, production, laboratory operations, facilities & equipment, materials management, and data integrity.
Accurately identify non-conformances and potential compliance risks.
2.Reporting and Follow-up
Prepare professional, clear, and objective audit reports in English, documenting findings and conducting risk assessments.
Track and evaluate the appropriateness and effectiveness of clients’ corrective and preventive action (CAPA) plans.
3.Knowledge Management & Internal Coordination
Maintain effective communication with the audit operations team and other collaborating departments.
Participate in internal auditor training programs and contribute to the update and maintenance of the knowledge base.
工作地点
上海杨浦区黄兴路300 号

客户公司信息
客户公司名称 某大型公司
客户公司地址 北京昌平区
客户公司人数 100-299人
认证资质
营业执照信息 人力资源服务许可认证

更新于 今天




