Quality Assurance Specialist
Pubblicato il 12-08-2026 - Sanofi in Italia
Job Title- Quality Assurance SpecialistLocation- GoaMain 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 coordinator 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 controls.Initiation of deviation and support in deviation investigation.Support in Market Complaint investigation.Implementation of assigned CAPAs and support in closure.Implementation of assigned Efficiency Reviews (ERs).Act as PPO (Primary Process Owner) for QMI (Quality Maturity Index) as assigned.Batch release & response to queries from QP.Management of Data integrity aspects.Participation and support in SMS initiatives. Support for HSE activities.Handling of Site Master File (SMF).Calibration document review of Engineering/QC/PMTD.User access management & reviewAnalytical method creationAudit trail reviewDocument archival/retrieval management.Validation & Q