Engineer/Sr. Engineer Compliance 合规工程师社

面议

泰州市

发布时间：2023-09-06

职位描述

External/Internal GMP Inspection
-Prepare annual plant internal audit plan
-Maintain internal &external audit system and ensure its implementation
- Carry out internal audit
- Prepare training plan of internal auditor and manage internal auditor certification process
- Coordinate external GMP inspections
- Coordinate CAPA creation, review and follow-up CAPA implementation Compliance affairs
Compliance affairs
-Prepare and submit the documents for GMP certification and filing etc.
-Maintain GMP relevant license and ensure validity.
-Document and data preparation and submission to authorities
-Support regulatory affairs, and coordinate and carry out the review of registration dossier within Taizhou site
-Keep good communication with authorities
Change management
- Establish and maintain change management system based on GMP and QCM requirements
- Coordinate, coach and supervise effective execution of change control
- Review and approve global and local changes
- Organize change review meeting to ensure all changes are reviewed effectively
- Provide effective training and support to change users
GMP requirements
- Establish and maintain quality management system based on GMP requirements
- Supervise effective execution of GMP
- Provide GMP support, suggestion and training to other functions Regulatory Compliance
- Focus on changes of regulations and impact assessment, and communicate with other functions
- Ensure regulatory compliance of quality management system
Supervisory responsibilities
-Assist the team leader to manage daily job in compliance department
-Assist the team leader to build and develop team capability


Quality Management System Business
- Ensure that the CIP is generated, maintained and regularly reviewed.
- Ensure that the Quality Management Review meeting is organized, actions are tracked and keep continuous improvements.
SHE responsibilities


Requirements


University graduate or above
Good GMP and quality system management knowledge.
Ten years plus experience in the Pharmaceutical Industry, with at least seven years’ experience in QA.
Multiple site or function experience
Good Engli*********************

其他要求

招聘人数：1人
职能类别：医疗器械生产

公司介绍

在阿斯利康，我们引领健康医疗未来。

如果你有志于投身生产运营领域，阿斯利康无锡和泰州供应基地将为你提供未来无限可能。

一份高品质的工作：追求质量的你，把控阿斯利康药品生产供应环节中的每个细节，确保我们输送到患者手中的是一份安心；
一份有意义的工作：超越一般的流水线工作，我们为健康负责， 惠及亿万患者的生命；
一份全球化的工作：立足中国的药品生产，辐射全球市场，我们融合国际先进的生产运营技术；
一份有归属感的工作：轻松简单的团队氛围，以共同的生产指标为导向，共同努力，开放包容的沟通；
一份无后顾之忧的工作：安全生产，福利薪酬，为你保驾护航；
一份挑战舒适圈的工作：拒绝日复一日的重复，我们不断创新，不断将创新技术融入生产运营，提升自我知识和技能的同时，也提高生产效率效能；

加入阿斯利康，在生产运营***线，成就一份惠及他人、实现自我的事业。