质量合规副经理社

面议

市辖区本科及以上7年及以上

发布时间：2023-09-06

职位描述

基本目标与范围 Basic Purpose & Scope
作为SJJP的SPOC，支持QS高级经理负责SJJP Make的质量合规工作 As SJJP’s Single Point of Contactor, support Sr. Compliance Manager to conduct compliance activity for SJJP
应对外部审计和**沟通ndline External Audit and coordinate HA communication负责SJJP内部的审计管理，如内审管理，JJRC 审计 Handling SJJP internal audit management, e.g. internal audit, JJRC audit.
从质量方面支持SJJP 的NPI/NPD 项目管理 Support SJJP NPI/NPD project in Quality aspect.
SJJP的法规变化追踪 SJJP Regulation GAP Assessment

主要工作任务与权限Responsibilities / Authority:
在上海强生制药，支持高级质量合规经理根据中国和相关销售国关于生产及产品管理法律法规、强生总部的指导纲要及ISO等国际行业标准，建立、实施并维护适用于公司的质量体系流程和标准作业规范，并采取必要措施改善作业以保证其持续合规有效性。 In SJJP, Support Sr Compliance Management to Lead and coordinate the establishment and maintenance of quality management system and process in compliance with relevant regulations, J&J enterprise guidance/ policies and relevant international standards such as ISO etc., Initiate appropriate actions to ensure sustainable system compliance and effectiveness.
负责上海强生制药的相关证件的更新和维护，协调准备和递交相关备案文件，如药品生产许可证，GMP，食品经营许可证等。 Handle SJJP’s government license/certification application/renewal, coordinate the dossier preparation and make submission. e.g. Drug manufacturing license, GMP license, Food distribution license etc.
接待和处理外部**针对上海强生制药的审计管理活动，并协调审计的预先准备和后期整改行动的实施。 Handle SJJP external HA audit management, including coordinating audit readiness and CAPA implementation.
负责SJJP内部质量审核活动，按既定审核计划及时完成所分配的审核任务活动，包括预备沟通、实施审核、完成报告、复核整改方案及跟踪结案等事宜。 Handle SJJP Internal Audit Management; conduct assigned internal audit activities per planned schedule including pre-communication, auditing, completion of report, verification of CAPA proposal, following CAPA execution and closure.
作为QA 代表，参与SJJP的NPI/NPD 项目，处理和支持质量和合规方面工作，如澳洲T500，新加披T500，中国加速项目等。 As QA representative, anticipate SJJP’s NPI/NPD project, handle and provide Quality and Compliance support, e.g. Tylenol tablet 500mg (Australia, Singapore), China OTC acceleration.
按照要求定期收集和汇总质量体系执行状况指标，如管理评审，月报等。 In SJJP, periodically collect and report the quality KPIs per requirements e.g. monthly report, management review etc.,
及时跟踪药品生产产品相关的生产许可、以及良好生产质量管理规范(GMP)及行业标准的变化，并在SJJP内部协调和跟踪内部的评估和落实。 Timely track changes of drug manufacturing license and GMP related regulation and industry requirements associated with manufactured products, coordinate internal assessment and follow up deployment inside SJJP.
上级主管交付的其它工作。 As per other assignments by direct supervisor if necessary.


任职资格Qualification:
1. 教育背景
Education background:
化学制药或相关学科本科或以上学历 Bachelor degree or above preferred on Chemistry, Pharmacy or other relevant science
2. 相关经验
Relevant experience
熟悉了解药品相关的国内国际质量体系及法规要求, 以及质量体系的建立及其合规维护od understanding of regulatory and other international requirements on drug. Previous knowledge and experience in establish and maintenance of quality system and compliance 至少3年以上相关工作经验 least 3 years related working experience 3. 其他技能
The other skills
能自我激励，擅长沟通和团队合作lf-motivated, with good communication and team collaboration skills英文流利，说写自如 Fluent English in both writing and speaking
熟练操作各办公应用软件 Good knowledge of Computerized Software
工作汇报技巧娴熟 Good presentation skills

其他要求

招聘人数：1人
职能类别：

公司介绍

上海强生制药有限公司诚聘