原料药QA总监

面议

浙江省

刷新时间：2023-11-16

职位描述

QA总监职责
Responsibility for QA Director

1 目的Objective
1.1 明确QA总监职责，履行其职能。
Specify the responsibility of QA Director, fulfill its function.

2 范围Scope
2.1 适用于QA总监。
Apply to QA Director.

3 责任Responsibility
3.1 QA总监有责任履行其管理职能。
QA Director has the responsibility to fulfill its management functions.

4 教育背景和任职资格Education background and Qualification

项目
Item 内容
Content
教育背景
Education Background 4.1 具有化学、制药及相关专业本科及以上及海外经验 (首选) 学历
Bachelor’s degree or higher and foreign experience (preferred) in chemistry or pharmaceutical or related majors.
任职资格
Qualification 4.2 具有至少10年制药行业从业经验，其中至少五年的药品质量管理经验。
At least 10 years work experience in pharmaceutical industry, including at least 5 years pharmaceutical quality assurance management experience.
4.3 接受过制药行业和cGMP质量管理相关的专业知识培训。
Received professional knowledge trainings related to pharmaceutical industry operation and cGMP quality management..
4.4 具有一定的英语能力，能与国外客户和**部门进行有效的沟通。
Proficient in English, able to effectively communicate with foreign customers and regulatory agencies

5 工作内容Content
5.1 在公司质量副总裁领导下负责宁波公司质量保证工作。
Under the leadership of company’s Quality Vice President, be responsible for the Ningbo Site overall Quality Assurance management.

5.2 学习药品法律、法规，以指导质量管理工作。
Study pharmaceutical regulations and related laws, and guide the quality assurance management work.
5.3 依据《药品生产质量管理规范》、ICH建立、完善质量管理体系,以指导生产全过程的质量活动。
Based GMP regulation and ICH guidelines, to establish and improve quality management system, and guide the quality activities in the whole production process.
5.4 负责建立质量保证人员的岗位职责。
Establish the job description for QA personnel.
5.5 负责审核和批准所有与质量有关的文件。
Review and approve all quality-related documents.
5.6 确保所有偏差进行了调查并已解决。
Make sure that all deviations are investigated and resolved.
5.7 确保放行与拒收原料、中间体、终产品、包装材料和标签的系统符合GMP法规要求。
Ensure the system to release or reject raw materials, intermediates, final products, packaging and labeling materials in compliance with cGMP requirements.
5.8 批准所有与质量活动有关的变更，偏差，CAPA，OOS 调查工作。
Approve all quality-related change controls，deviations, CAPAs, OOS investigation activities.
5.9 确保调查并解决质量问题的投诉。
Make sure that quality-related complaints are investigated and resolved.
5.10 确保有稳定性数据支持中间体或原料药的复检期或有效期和储存条件。
Make sure that retest or expiry dates and storage conditions of APIs and/or intermediates are supported by stability studies.
5.11 评估和批准物料供应商。
Evaluate and approve material suppliers.
5.12 审核并批准验证方案和报告。
Review and approve validation protocols and reports.
5.13 批准所有的规格标准。
Approve all specifications.
5.14 确保用有效的体系来**和校验关键设备和仪器。
Make sure that effective system is in place for maintaining and calibrating critical equipment and instruments.
5.15 负责GMP培训与考核。
Be responsible for GMP training and assessment.
5.16 负责国内外客户和**部门审计。
Be responsible for domestic/international customer audits and regulatory agency inspections.

5.17 确保定期进行内部审计。
5.18 Make sure that internal audits are conducted regularly.
5.19 负责产品放行工作。
Be responsible for product releases.

5.20 确保数据完整性法规符合性。
Make sure in compliance with data integrity regulation requirements.

5.21 负责其它质量保证相关的工作。
Be responsible for other quality assurance related work as appropriate.


QA总监/QA Director： 日期/Date：

质量副总裁/VP Quality： 日期/Date：

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。