Executive Quality Assurance Subbiano

Executive Quality Assurance
Subbiano
Toscana, Subbiano

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 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 QualificationsQuality focal point for all validations (Process, cleaning, transport computerized system) and qualification activities. Quality focal point for temperature/ relative humidity mapping activities. Quality focal point for study related to hold time of products, cleaned/uncleaned equipment hold time, campaign length. Quality focal point for utilities purified water system. Management of Site Qualification Validation Master PlanIn-Process Quality Assurance (IPQA)Review Approval of Master Batch Records executed Batch RecordsReview and Approval of logbooks. Line clearance in Production. To perform In-process checks in Production. Sampling of products during routine production and validation. Quality oversight on shopfloor. HSEAdherence to all health safety environmental aspects as required by company policies and procedures. Ensure that the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement. Conducting daily training in the +QDCI meeting address any unsafe condition. Take suggestion from associates to improve the work conditions with great safety and zero risk. Periodic review of the implemented procedures and evaluation of the same. Train people on safety and their job to ensure zero LTI and IWLT at workplace. Languages: English, Hindi, Konkani, MarathiQualification: B. Pharm / M. PharmExperience-3-5 years experiencePursue progress, discover extraordinaryBetter is out there.

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