苏州招聘

Job description:
-Develop, improve and direct execution of equipment, processes, procedures, investigations, workflows, resources, skills and systems to support manufacturing and transfer products from development to manufacturing for both plant and contract products. Ensure that development provides cleaning methods, testing procedures, processes and process controls that provide a robust and compliant process transfer to manufacturing.
-Create, review and approve validation and manufacturing procedures, batch records, protocols, reports, and studies. Design SOPs and systems to ensure that GMP regulatory requirements are met in the most efficient manner to minimize risks to the operation.
-Work with manufacturing and product development to solve difficult technical problems and coach manufacturing personnel in solving technical problems. Design and implement management controls for improving manufacturing processes
-Organize and provide training for manufacturing and engineering employees on procedures and equipment relevant to manufacturing, cGMPs and validation.
-Understand and be able to explain requirements for instrument, equipment and computer systems and the CFR 11 regulatory compliance requirements. Work with the Manager to ensure compliance.
-Direct the equipment calibration program.
-Other tasks assigned by Manager.


Skill
-Experience in process validation, equipment validation, systems validation and cleaning validation.
-Knowledge and hands on experience of process engineering, formulation science and process chemistry in solid oral dosage
-Understanding of FDA, ICH and USP requirements for Drug Product development and manufacturing
-Understanding of manufacturing operations.
-Experience executing Technical Transfers
-Proficient developing and writing batch records, technical reports, protocols, methods, SOPs and other GMP lab documents in English and Chinese


Company Profile
Our client is a multinational company with established development and manufacturing platforms aimed at providing high-quality generic pharmaceutical products. With pharmaceutical assets and science-based expertise in the United States and abroad, our client is able to provide quality products at competitive prices along with unmatched customer service. And our Suzhou plant has successfully passed an US FDA audit in 2010. During this audit, the US FDA confirmed that the facility is capable and has quality systems which can produce pharmaceutical drug products to be exported into commercial commerce in the U.S. market

www.randstad.cn