北京招聘

岗位职责：
?Oversee the operations of the QC lab group to ensure accurate results, adherence to US FDA and CFDA regulations, cGMP/GMP, company protocols, and timely completion of projects. Recommend quality control equipment purchases to maintain the throughput of the testing of samples and provide expert advice on the qualification and maintenance of QC equipment as required.
?Provide expert guidance to Engineering, Validation, Calibration, Manufacturing, R&D, and other departments regarding quality and cGMP/GMP issues to ensure compliance with regulated standards. Participate on quality focused committees or in meetings, as required, concerning quality standards and/or compliance.
?Coordinate and supervise the collection data reported in the Annual Product Review.
?Prepare and/or review documentation required for regulatory submissions. Participate in the generation and review of Company Standard Operating Procedures.
?Review and authorize Certificates of Analysis and purchase requisitions.
?Ensure EHS requirements being met within QC function.
?Other tasks assigned by superior.

任职要求：·
·Bachelor Degree or above in Chemistry, Analytical Chemistry or related major, Master Degree is preferred;
·At least 10 years plus professional experience with management responsibilities within pharmaceutical Quality Control.
·Knowledge of US FDA and CFDA standards;
·Knowledge of US ANDA;
·Quality Auditing
·Equipment, process and cleaning validation
·Method development transfer and validation
·QC lab operations and data management
·Strong Management Skill and leadership
·Goal/task- oriented, strong sense of urgency organized and team leader.
·Strong Communication Skills in both written and verbal.
Fluent English

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