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职位名称:QA/QC Manager
职位类型:全职
工作经验:10年以上
学历要求:本科
招聘人数:1名
发布时间:2015-11-16
职位描述
1.Lead employees of department to achieve targets and control cost according to budget. 2.Fulfill and control implementation of all relevant change related internal & external topics, HSE, GMP and compliance ect. 3.Establish training and management’s procedure and ensure employees of department to hold necessary skill, and gain good performance. 4.Responsible for OE project and implementation together with conditions improvement to increase efficiency , lower cost and so on. 5.Complete function’s report monthly according to KPI 6.Ensure respective SAP system runs in good condition 7.Assures the development of, and adherence to, meaningful QA specifications for all raw materials, components, intermediates, and finished products. 8.Assures compliance with Bayer HealthCare policies and directives and current Good Manufacturing Practices(cGMP's), SFDA requirements, and agreed upon third party (customer) Quality Agreements. 9.Provides QA approval systems for new products, trials, data reviews, and raw material changes, process changes, immediate container approvals, and other similar processes that require coordination with regulatory affairs, medical and other R&D functions at BCC Headquarters. 10.Evaluate and authorize release for sale all Qidong produced products for both domestic and international distribution that are judged to meet corporate, divisional, and government regulatory requirements 11.Ensures adequate follow-up to all internal and external audit reports and findings to correct any deficiencies identified (e.g. SFDA, TAC, 3rd Party Customer). 12.Manages all quality related regulatory inspectional activity at the site and assures proper communication during an inspection to Global BHC QA, Regional Management and 3rd party customers. 13.Provides analytical lab testing support and regulatory consulting service to the Process Technology department as they work to optimize manufacturing processes, reduce production costs, and resolve technical problems.
招聘要求
1、Bachelor or above , Major in chemistry/pharmacy or other related speciality; 2、More than 10 working experiences in Quality field and 5 years working experiences in this position; 3、Preferred to having working experiences in multinational company with strong GMP consciousness; 4、Good command of English in oral and writing. 5、Good Communication and cooperation skill ,
联 系 人:tiger
联系电话:0517-8696 2515
电子邮件:tiger@topcnhr.com
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