QCDirector/高级经理

40-60万元/年

苏州市

刷新时间：2022-12-14

职位描述

Job Functions

Including but not limited to,

· Lead and manage the QC team for overall QC activities in compliance with cGMP;

· Promote collaboration and communicate with other functional areas and ******s to ensure timely completion of QC activities to meet project timeline

· Assist higher management to schedule resources, coordinate laboratory activities, improve data and document quality to meet ****** expectation.

Develop training program. Ensure all staff receive training in basic cGMP training, applicable techniques and SOPs;

· Lead the specification and procurement of equipment, start-up, commissioning and testing of Quality Control Laboratories for clinical and commercial biologic products;

· Lead the technology transfer of analytical methods, testing protocols, etc.;

· Provide guidance and oversee method qualification/validation, troubleshooting, laboratory and OOS investigation;

Manage the overall QC operations to support GMP operations;

· Manage the program of testing encompassing raw materials, environmental monitoring, testing critical utilities (e.g. WFI, PW, special gases, HVAC), intermediates, bulk drug substances, and drug products are required; and

· Provide technical support at the Subject Matter Expert (SME) level for guidance on test methods and procedures.

Quality Assurance 质量要求

· Comply with the Company Quality Management Systems: specifically Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP);

· Author new and revise documents related to QC processes and equipment;

Review and approve technical documents such as methods, qualification/validation protocols and reports;

· Participate in investigation teams, and provide input to quality systems (change control, CAPA, and deviations).

General 常规要求

· Manage Quality Control Unit expenditure and project CAPEX in line with budget;

· Comply with general Company Policies and Procedures and contribute positively to Company morale; and

遵守公司政策和程序，积极提升公司士气；

· Other reasonably duties as requested by manager from time to time.

有时需完成公司管理层提出的其他合理任务。

Qualifications 学历

· B.S (preferably Biology or Chemistry) or related life sciences degree

Essential Experience 任职资格

Minimum 8 years of relevant experience that demonstrates an expertise in assay qualification/validation, release and stability testing and QC operations;Minimum 4 years of operational experience in a regulated biopharmaceutical manufacturer with exposure to facility start-up;Extensive hands-on and technical experience in physical chemistry, bioassay, microbiology, environmental monitoring, raw material testing and QC operations in cGMP environment;Strong knowledge of GMPs and quality systems with experience managing deviation, change control, and CAPA. Assist regulatory audit and inspections;Excellent communication skills (both verbal and written) and interpersonal skills are required. Fluent in English and Chinese;Managerial experience by providing on-going mentoring, supervision, and yearly performance review and appraisal of a large group of scientists;Experience in managing a team of at least 20 people;

· Responsibility for operation of pharmaceutical Quality Control laboratories processing more than 1,000 samples/month; and

· Expert user of Microsoft Office applications (MS Word, Excel, Outlook).

其他要求

招聘人数：1人
职能类别：QC总监/QC经理/QC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。