QA经理/高级经理（质量保证）

面议

市辖区硕士及以上

刷新时间：2021-03-31

职位描述

工作职责
1.建立，维护和监视QMS（质量管理体系），以满足特定国家的监管机构的要求：
•设计，实施和改善公司质量标准
•分析数据以确定增长领域
•协助招聘过程
•培训，激励和指导员工以确保达到标准
•制定提高生产力的策略
•审查流程，以确保它们符合行业标准
2.药品合同制造组织（CMO）的质量监督，包括但不限于：
•赞助原料药和药品的最终审查
•审核和批准CMO提供的文件
•领导计划，执行，监视，控制和结束项目。
•监督临床产品的处置
•以有意义的方式执行质量协议
•执行资格和审核
3.根据当前行业标准维护和控制受控文件系统。
4.与监管机构沟通所有监管文件。
5.维护和控制从事GMP活动的顾问的身份，资格和职责的文件。
6.保留质量报告，统计评论和相关文档的记录。
7.审核，鉴定，监视和终止用于公司产品制造的关键供应商。

工作要求：
•最好是药物科学或化学硕士学位
•至少4年的制药行业成功经验
•全面了解制造能力，药物开发，质量管理系统（QMS）和风险管理的核心竞争力
•除了出色的口头和书面沟通外，还具有出色的组织，计划和整体时间管理技能的良好记录
•能够识别并进行持续改进的计划
•出色的数值和数据分析/统计技能
•具有编写SOP，协议，调查报告，年度报告和其他文件的经验
•渴望帮助团队实现最佳状态
•高度重视细节和注重结果的方法

•英文流利

Job Position: Manager / Sr. Manager,
Quality Assurance

­­­

Job Responsibilities

1. Establish,
maintain, and monitor QMS (quality management
system) in order to meet country-specific regulatory authority requirements:

·
Design, implement, and improve company quality standards

·
Analyze data in order to identify areas for growth

·
Assist in the recruiting process

·
Train, motivate, and coach employees to ensure that standards are met

·
Formulate strategies to increase productivity

·
Review processes in order to ensure that they are aligned with industry
standards

2. Quality
oversight of pharmaceutical Contract Manufacturing Organizations (CMOs),
including but not limited to:

·
Sponsor final reviews of APIs and drug products

·
Review and approve documents provided by CMO

·
Leadin planning, executing, monitoring, controlling and
closingprojects.

·
Oversight the disposition of clinical products

·
Enforce quality agreements in a meaningful way

·
Perform qualification and auditing

3. Maintain
and control the controlled document system according to current industry
standards. 

4. Communicate
with regulatory agencies for all regulatory documents.

5. Maintain
and control the documents of identity, qualification, and responsibilities of
consultants who are engaged in GMP activities.

6. Keep
records of quality reports, statistical reviews, and relevant documentation.

7. Audit,
qualify, monitor and terminate the Critical Suppliers used for company’s
product manufacturing.



 Job
Requirements:

·
Preferably a Master’s degree in Pharmaceutical Science or Chemistry

·
A minimum of 4 years of successful experience in pharmaceutical industry

·
A comprehensive understanding of the core competencies of manufacturing
capabilities, pharmaceutical development, quality management system(QMS),
and risk management

·
A proven track record of exceptional organizational, planning and
overall time management skills in addition to exceptional verbal and written
communication

Ability to identify and to
carry on continuous improvement initiatives
Excellent
numerical and data analysis/statistical skills
Experiences in writing SOPs,
protocols, investigation reports, annual reports, and other documents
A
desire to help team achieve its best
Great
attention to details and a result driven approach
Fluent
in English writing      

其他要求

招聘人数：1人
职能类别：QA总监/QA经理/QA主管

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。