Quality-Assurance-Director

面议

无锡市

刷新时间：2022-07-04

职位描述

Key Responsibilities:
1.Establish and manage the quality system in order to comply with cGMP and international regulations including China, EU and FDA regulations.
2.Responsible for review and approval of the quality system procedures and documentations which covering the life cycle of drug product, from clinical trials, commercial production and post-marketing monitoring.
3.Responsible for maintaining and continuously monitoring of the overall quality compliance status for all GMP activities to ensure the fulfillment of company quality policy and regulatory expectations.
4.Responsible for monitoring, supervision and oversight of the quality activities for product manufacturing process including but not limit to review and/or approval of: equipment qualifications, process validations, product manufacturing and batch release, GMP environment control, material specifications, calibrations, customer complaints, deviation handling, CAPAs, Change control management, etc.
5.Responsible for the continuous improvement of the quality system performance, leading the self-inspections and internal audit to ensure all quality activities been over-sighted.
6.Lead and monitor the investigations, CAPAs, risk management, self- inspections, Change controls, and other quality activities. Responsible for preparing and leading all regulatory audit/inspection. Ready to answer all quality related answers and take the responsibility of corrective actions and continuous improvement of the performance of quality system within the company.
7.Responsible for planning maintaining and managing QA organizational budget, capital spending and resources allocations.

Qualifications:
1.Master, or PhD Degree in Chemistry, Biochemistry, Biology, Pharmaceutical. Biological Engineering, or related field.
2.Minimum 15 years’working experience in Bio-Pharmaceutical industry (Vaccines industry is an advantage) of which 10 years’experience in Quality Assurance.
3.Experience in Chinese regulatory inspections is a must and in FDA and EU inspections is an advantage.
4.Excellent knowledge of Chinese cGMP/EU/FDA and international regulations, guidelines and inspections.

Flexibility of the Job
1.Exposure to biologics, ADCs, and vaccines.
2.Opportunities to have a deep understanding of the quality operation of several sites, and most likely be assigned as Site QA head.

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。