Ankur Kumar

 Responsible to ensure cGMP compliance for QMS documents.  Responsible for review, approval and closure of QMS elements such as deviations, change controls, CAPA, market complaint, recall & training handling and to take proactive actions. Responsible to ensure the regulatory & customers communication for deviation / change control / OOS and other documents. Responsible to track a CAPA closure and effectively present the CAPA system to management on periodic basis. Review and verification of documents for CAPA implementation and closure. Responsible for investigate failure investigations / events and resolution of product related deviations. To ensure timely completion of QMS documentation in consultation with all department heads. To ensure the completion of QMS trends reports within stipulated timelines. To ensure the quality complaints investigation, review of investigation process for root cause and initiate the appropriate CAPA. Responsible to perform and evaluation of risk assessment (FMEA, HIRA etc.), related to process, facility, safety and general. To participate and manage customer and regulatory partner and internal audit with regarding to QMS documents. Self-inspection and / or quality audit, which regularly appraises the effectiveness and applicability of the QA system. To approve or reject the vendors supplying raw materials, packaging materials based on quality matrix report. To ensure the timely execution of vendor audits as per audit schedules & revisions of documents.Software Handling:Handling of SAP, Track Wise,DMS,SCM,CAMS andMy-Satu Softwares.Audit Exposure:EU-GMP Malta, PIC’S- Ukraine, NAFDC- Nigeria, MSF- Belgium, WHO CDSCO India, INVIMA GMP Certification for Colombia, ISO-9001:2015, 45001 & 14001:2015, Food Safety and Standards Authority of India (FSSAI) and Consultant audit of WHO-Geneva & TGA-Australia