长沙招聘

职位描述：
Position Summary
The incumbent will have demonstrated strong technical knowledge and cGMP compliance, with respect to small molecule clinical drug manufacturing and commercialization. This individual must have demonstrated capabilities in execution of risk-based and compliant quality system, and compliance programs that adhere to regulatory expectations.
Principal Responsibilities
? Responsible for ensuring that all investigational and potential commercial drug products are manufactured in accordance with client’s requirements and in compliance with the cGMPs.
? Responsible for timely review and release/disposition of clinical trial supplies/ drug product to support client’s goals.
? Oversee qualification, performance tracking, and manage health authority inspections, and internal/external audits. Provide recommendations for corrective and preventative action to the functional areas
? Review and approve analytical/stability protocol, data and reports, maintain stability data base, review and approve micro testing and report. Approve and issue specifications, and methods for drug products
? Review and approve IQ/OQ/PQ and validation protocols for manufacturing equipment and facility, support qualification/validation of GxP related computer based systems. Maintain Quality documentation files, databases, and logs.
Position Requirements
? Extended experience in Quality Assurance with demonstrated increasing expertise and responsibility in the pharmaceutical industry
? Previous experience in building and leading Quality Assurance group, and ability to influence others and able build a company culture of quality
? Expert knowledge of FDA and ICH quality regulations with respect to all aspects of drug development; clinical, nonclinical and CMC
? Experience in bringing products from clinical to commercial and understanding appropriate GMP requirements.
? Strong understanding of manufacturing processes for drug products. Experience with electronic data systems preferred
? Excellent written and verbal communication skills 举报 分享

药明康德是国际领先的开放式能力与技术平台公司，为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任，以客户为中心的宗旨，药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等，正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目，致力于将最新和***的医药和健康产品带给全球病患，实现“让天下没有难做的药，难治的病”的梦想。