北京招聘知名医药外资 - 高级质量合规专员 / 助理经理

知名医药外资 - 高级质量合规专员 / 助理经理

万宝盛华企业管理咨询（上海）有限公司

公司规模：1000-5000人
公司性质：外资（欧美）
公司行业：中介服务

职位信息

发布日期：2020-12-16
工作地点：北京-朝阳区
招聘人数：若干人
工作经验：3-4年经验
学历要求：本科
职位月薪：2-3万/月
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

Major Responsibilities:

· Daily monitor regulation announcement that include, but not limited to: Local country regulatory websites (for ex. Local HA websites); Johnson & Johnson Websites (for ex. Enterprise Regulatory Outreach); and from Professional organization websites and meetings and tracking following the SOP.

· Support to evaluate regulation and identify changes to existing standards listed in the local Quality Manual or new standards that could potentially impact the organization.

· Support business quality manager to track business areas impacted by the proposed changes and disseminate new or revised regulatory standards information to the affected business areas to aggregates feedback from affected business areas SME’s and determine the organization impact of the changes, communicate the impact assessment to business unit management and stakeholders, including through Management Review.

· Support business quality manager to ensure that the new or revised regulatory standards requirements are addressed by following the applicable business unit change control procedure and he/she ensures necessary compliance actions are properly documented.

· Monitor and ensure the appropriate implementation and follow-up of actions needed to comply with new regulatory standards through existing processes such as Quality Issue; Management Review and Internal audits.

Quality & System Elements: The regulatory compliance representative is responsible to: Quality System:

· Support Business Quality Manager to maintain and implement Quality System via transposition of the applicable requirements (laws, regulations and the elements of the J&J quality policy, standards and procedures etc.).

· Support Business Quality Manager to drive MAH workstream and gap assessment, and drive mitigation plan define and execution

· Drives temporary/short term additional tasks as are assigned by the Business Quality Manager, i.e. deployment of new quality IT tool or quality projects/ processes within the LOC

Document, data and Change Controls:

· Prepare and update LOC procedures in accordance with local GxP, BQ and J&J requirements

· Execute minimum requirements regarding lifecycle management of GxP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity. · Ensure appropriate internal and external change control systems are followed.

Qualification and Training:

· Prepare, update, train and implement global BQ/local LOC procedures in accordance with local GxP, BQM and J&J requirements

· Notify and engage LOC Head of Business Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in BQM

Job Requirements：

· Bachelor’s degree or higher in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline;

· Experience in regulatory policy activities gained within China, region, national health authority, industry or trade associations

· Good working knowledge of the China regulatory framework and how that applies to pharmaceutical and healthcare product development

· 3- 5 years’ experience in the Pharmaceutical or related industry, ideally with a mix of Quality and Compliance (GxP), Regulatory Affairs. Quality Compliance and Regulation experience is essential;

职能类别：药品生产/质量管理质量管理/测试主管(QA/QC主管)

关键字：质量合规 GMP

公司介绍

万宝盛华大中华有限公司，1997年服务启航于香港和台湾。迄今服务覆盖上海、北京、广州、深圳等逾20座直营城市。我们的大股东万宝盛华全球（ManpowerGroup Inc. NYSE:***）是全球人力资源解决方案领导者，拥有70年服务经验。凭借万宝盛华全球的声誉及行业经验，万宝盛华大中华深耕本土20余年。2015年，万宝盛华大中华战略联盟中信产业基金，总部落地上海，服务网络覆盖两岸三地130余城市逾两万家企业。我们始终致力于释放人才的发展潜能，凭借灵活用工、人才寻猎、招聘流程外包、人才管理及培训发展等人力资源综合解决方案，广受业界赞誉，屡次荣膺“亚太人力资源领军企业”。

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