北京招聘

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

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