Job Title: Quality Assurance SpecialistLocation: Goa Site, Verna Industrial Estate, Salcete, Goa, IndiaAbout the jobJoin a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.
About Sanofi: We're an R&D-driven;, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main responsibilities:
Management of Quality SystemsCompilation, Review & Management of overall Product Quality Reviews system.
Act as site coordinator for change controls & management of change control system.
Management of Deviation system.
Management of Market complaint investigation system.
Act as QA focal point for OOS/OOT management.
Management of Training system.
Oversight on Pest Control system.
To perform Nitrosamine Assessment & review.
Management of ICHQ3D requirements.
Site coordinaator for Implementation of Sanofi Global Standards (STDs) and Global Operating Procedures (GOPs)Act as focal point for Subcontractors/ Service Providers management.
Management of overall Validation systems (Process, cleaning, transport & computerized system)Management of CAPA System.
Quality Management SystemsCoordinating for conducting self-inspection as per planner and associated self-inspection activities.
Review and Approval of GxP documents, batch manufacturing record and batch packing record in electronic-document system.
Implementation of quality documents, management, and control of documents, such as SOPs, Master Documents etc. Coordination of cGMP training activity including training of the people & review of training module.
Initiation, implementation, and closure of change
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