QualityAssuranceManager/SeniorAuditor

面议

上海市

刷新时间：2023-10-12

职位描述

Main responsibilities:

1)Contribute to establishing an effective global risk-based audit strategy and program.
2)Plan, lead, conduct, document, and follow-up of GMP audit according to the requirements specified in the respective Opocrin quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
3)Prepare audit reports according to Opocrin requirements and timelines.
4)Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.
5)Support the suppliers of the Group supply chain with the authorization/exportation/regulatory procedures and documentation preparation.
6)Support the quality/regulatory units of the Group in gathering and reviewing the quality and traceability documents provided by the suppliers.
7)Implement and maintain the Quality System of the Company in accordance with GMP and Group internal standards.
8)In compliance with the objectives and times agreed with the Manager, collaborates in the preparation of the department budget.

Minimum requirements

• Degree in Chemistry, Pharmacy, Biology, Engineering or another related science
• Excellent oral and written English
• At least 5 years broad experience in Pharmaceutical Industry.
• At least 3+ years auditing experience.
• Willingness to travel approximately 60% of the time.

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。