Compliance Team Lead
Pharma operation - 北京诺华制药有限公司 北京昌平制药工厂
- 公司行业：制药/生物工程
职位信息
- 发布日期：2013-05-14
- 工作地点：北京-昌平区
- 招聘人数：1
- 工作经验：三年以上
- 学历要求：本科
- 语言要求：英语熟练
普通话熟练 - 职位类别：药品生产/质量管理 质量管理/测试主管(QA/QC主管)
职位描述
Responsibilities:
? Ensure the API, Excipients, Primary Packaging Material Supplier and Secondary Packaging Material Supplier used in PO complies with the local Pharmaceutical Authorities updated GMP requirement.
? Coordinate and monitor Change Controls and Calibration/Validation activities.
? Handle and monitor complaints from <PO< for supplies of DS, Excipients and bulk from Novartis.
? Handling local and EU, WHO, TGA health authorities' inspection.
? Responsible for site quality risk assessment and site quality plan preparation, with CAPA follow up.
? Identify repetitive activities and regulatory areas for which SOPs are required. Initiate the introduction of SOPs.
? Plan, initiate and monitor basic GMP-training for all <PO<Employees in regular intervals. Be responsible for Annually GMP Training Program and implementation.
? Identify quality related weak-point and gaps in production, QC, Engineering, Production Services, General Services and QA, in general and, in particular, deriving from unrecognized errors in routine activities. Initiate corrective measures and investigation report.
? Establish trend analyses regarding the quality of the Products and initiate investigations and measures to reverse trends nearing alarm limits.
? Maintain access to regulatory and pharmaceutical Authorities in respect to up-dated GMP knowledge and provide latest know-how in the field of GMP and other quality related fields.
? Handle complaints from internal and external customers, until the cases are closed.
? Establish and responsible for supplier audit and qualification system for local Raw Materials and PPM.
? Attend to any other work related assignment, which may be given by the superior.
Requirements:
? Bachelor degree or above in related Major
? Fluent communication in both English and Chinese
? 4-6 years experience in the quality assurance field in Pharmaceutical industry, JV experience has priority
? Supervisory functions in quality assurance.
? Practical experiences in compliance and QC.
? Ensure the API, Excipients, Primary Packaging Material Supplier and Secondary Packaging Material Supplier used in PO complies with the local Pharmaceutical Authorities updated GMP requirement.
? Coordinate and monitor Change Controls and Calibration/Validation activities.
? Handle and monitor complaints from <PO< for supplies of DS, Excipients and bulk from Novartis.
? Handling local and EU, WHO, TGA health authorities' inspection.
? Responsible for site quality risk assessment and site quality plan preparation, with CAPA follow up.
? Identify repetitive activities and regulatory areas for which SOPs are required. Initiate the introduction of SOPs.
? Plan, initiate and monitor basic GMP-training for all <PO<Employees in regular intervals. Be responsible for Annually GMP Training Program and implementation.
? Identify quality related weak-point and gaps in production, QC, Engineering, Production Services, General Services and QA, in general and, in particular, deriving from unrecognized errors in routine activities. Initiate corrective measures and investigation report.
? Establish trend analyses regarding the quality of the Products and initiate investigations and measures to reverse trends nearing alarm limits.
? Maintain access to regulatory and pharmaceutical Authorities in respect to up-dated GMP knowledge and provide latest know-how in the field of GMP and other quality related fields.
? Handle complaints from internal and external customers, until the cases are closed.
? Establish and responsible for supplier audit and qualification system for local Raw Materials and PPM.
? Attend to any other work related assignment, which may be given by the superior.
Requirements:
? Bachelor degree or above in related Major
? Fluent communication in both English and Chinese
? 4-6 years experience in the quality assurance field in Pharmaceutical industry, JV experience has priority
? Supervisory functions in quality assurance.
? Practical experiences in compliance and QC.
公司介绍
Pharma operation - 北京诺华制药有限公司 北京昌平制药工厂诚聘
联系方式
- Email：chen.li@novartis.com