验证总监/高级总监

面议

市辖区

刷新时间：2023-11-06

职位描述

ZhenGe Biotech

Established in 2017, Shanghai ZhenGe Biotechnology Co., Ltd. (ZhenGe Biotech) is a premier high-tech enterprise registered in the China Pilot Free Trade Zone (Shanghai). ZhenGe Biotech has Development Centers in Shanghai and Innovation Center in Maryland USA, as well as cGMP and commercial manufacturing sites in Shanghai.  The core business of ZhenGe Biotech is to provide CDMO services to both biotech and pharmaceutical companies.

Our integrated CDMO services starting from pre-clinical research to commercial manufacturing, as well as customized cell culture media development, enable and accelerate the R&D and commercialization of innovative biologics for biotech and pharmaceutical companies worldwide.

Zencore Bio is the wholly owned subsidiary of ZhenGe Biotech, located in Germantown, Maryland.

Position: Quality Validation Director

Report line: SVP of Quality

Location: Shanghai, China

Responsibilities:

lLeading & manage & hiring validation team

lSchedule & planning for project validation & existing facility Q&V

lDrawing , URS, project management document develop & review

lTendering for CU & Validation package

lC&Q SOPs development

lQuality system SOP review

lCSV system sop review and existing facility gap analysis and improvement

lProcess validation & Cleaning validation plan and risk analysis

lCritical vendor tendering 

lPAS system validation clarification and system doc. review

Qualifications

lBachelor’s degree or above; major in biology, pharmacy, chemistry, etc.;

lAt least 10+ years of experience in macromolecular biopharmaceutical industry, and 5+ years of management experience in the biopharmaceutical field.

lRich experiencein the field of Qualification & Validation project management and execution, Quality system, Quality control supplier audit, research & development of pharmaceutical

lHave variety experiences in leading Project Commissioning & Qualification activities and practical project validation management & execution skills on facility and equipment.

lGMP compliance audit experience of pharmaceutical company.

lHave strong career-ambition and sense of responsibility; embrace goal- and result-oriented management model; have strong executive ability, resource integration ability, team management ability and good interpersonal skills.

Company provides competitive compensation package, including stock options.

For more information, please visit https://zgbiotech.com/en/, or contact us at hr@zgbiotech.co****>

其他要求

招聘人数：3人
职能类别：验证经理/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。