QA Sr. Engineer
Suzhou, China Design / Civil engineering / Industrial engineering
Job description
Job Description
Ensure that aspects of the handling, manufacturing and distribution of pharmaceutical products at relevant fields ChemOps SNPT comply with the requirements of the Novartis Pharma Corporate Quality Manual and Policies and meet the relevant cGMP regulatory and legislative requirements e.g. Validation, qualification, batch release, change control, supplier management, laboratory compliance, etc. • Execute local Quality System and Standard Operating Procedures in compliance with cGMP is maintained through training and audit. Ensure that a high quality of products is achieved through qualification and validation based upon quality risk analysis. • Perform release of relevant raw materials, intermediates, packaging material and internal products in accordance with the registered specifications. • Perform, supervise and coordinate third party activities to ensure that manufacturing, (re-) packaging, (re labelling, storage and/or distribution of Novartis products are in compliance with Novartis Standards and regulatory requirement. Support on establish QA agreements as required. • Support implementation of key quality process such as documentation, deviations, validation, change control and relevant E-Systems management for relevant function. • Support management of site preparation for corporate and regulatory (e.g. FDA, SFDA) audits e.g. preparation /review of required documentation. Lead specific presentations on relevant topics during e.g. FDA, SFDA or corporate audits where appropriate • Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the relevant function.
Desired profile
Minimum requirements
• B.S or M.S or Ph.D in Pharmaceutics or chemistry related • Attainment of qualified/responsible person status under local/international legislative requirements Mandarin and English, fluent in listening/ speaking/reading and writing. At least 3 years in Quality Assurance and Quality Control and/or in a manufacturing environment within the pharmaceutical industry.