Overview
QA(J10100) Jobs in Shanghai, Shanghai, China at 山东赛诺菲电子科技有限公司
Title: QA(J10100)
Company: 山东赛诺菲电子科技有限公司
Location: Shanghai, Shanghai, China
该职位来源于猎聘 职责描述： 1、Maintain a robust manufacturing process at the contract manufacturers, including risk management and RCA; provide cGMP compliance support to Contract manufacturers by investigating and resolving quality issues; assist in the coordination of any product recall involving the contract manufacturer;
2、Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies; 3、Evaluate and/or release products to support clinical development with the assurance that the goods were produced in compliance with cGMP, the Applicable Laws and Regulations, the QAA and Project Contract;
4、Oversee contract manufacturing activities where necessary;
5、Evaluate, develop and support the quality level of contract manufacturers; review audit outcomes pertaining to contract manufacturers and ensure appropriate and timely CAPA are warranted; track and monitor operational and quality performance of the contract manufacturer/partner and work with supplier to develop CAPA plans where applicable; 6、Conduct routine and solves change requests and support process modification change controls; support routine process validation; review and approve validation reports/tech transfer; prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes; 7、Coordinate closely with business stakeholders such as CMC, Clinical Development, Regulatory Affairs, and Portfolio/Project Management to ensure business & compliance goals meet with the expected Abbisko and regulatory standards; 8、Participation in the completion of the internal audit schedule. Conducting the internal audits, reporting any findings and tracking completion of CAPAs; 9、Any other task as required by the business. 任职要求： Education：Bachelor degree or above in biology, chemistry, biochemistry, bioengineering, or a related life science field.Experience of working to GMP, ICH or other relevant regulatory requirements. Experience：6-8 years’ experience of working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company. Capability 1、To be proactive, cooperative and have good communication skills; 2、Experience of third party management and validation processes; 3、Critical review of CAPA / non-conformances / deviations / OOS; 4、Conducting final batch release; 5、Customer/vendor complaints or technical support experience; 6、Fluency in English, reading and written.
