Hema Sharma

More than 15 years Quality System Management, Process/Product Improvement and Leadership Management experience that have successfully drove strategic improvement efforts across multiple India global pharmaceutical organizations to achieve significant Quality System, Operational, Customer Satisfaction, Financial and Employee satisfaction impact. Brought Quality culture transformation and implementation of Quality excellence initiatives at site. Leading Quality Management System, SOP Development, and Continuous process improvement initiatives through the disciplined use of measurements, accountability, analysis and discussion of process alternatives in order to arrive at best practices; Directing and training cross-functional teams, including members of business/functional staff and external vendors; Delivering results that achieve or surpass projects targets based on compliance, ROI, customer satisfaction, and employee satisfaction improvement objectives; Meeting project timelines to manage realization of project benefits and maintain downstream effect on project funnel; Communicating to and influence stakeholders of all levels; Developing and maintaining productive relationships through individual contacts and group meetings. Area of Expertise: Assurance of E- Compliance in respect of current regulatory requirement., Computer System Validation assurance on the basis of risk management approach, Software Qualification and implementation as per 21CFR part 11, Annexure 11and PIC/S requirement. (LIMS, eDMS, eQMS).,Software implementation and Qualification of Quality control department like Empower 3, Lab solution, EDC, Opus etc., Batch release and reject as per scheduled time ,Stability study management and documentation for regulatory submission, Handing investigations, Root cause analysis and Quality Risk Management using tools of assessments., Handling CCM and effective monitoring, DV /Incidents, OOS, OOT and MCs with finally implementation of CA and PA with effective monitoring., AMT and MT as per regulatory market ,Process validation. /Cleaning validation/SOP/Annual Quality Review, and approve documents related to product specification, Standard Test Procedure and Raw data sheet. Training management system ,Water validation protocol, report, trend data and documentation ,In process handling on shop floor, Artwork review and approvals. Audit Exposure : WHO-Geneva, TGA, ANVISA, EU-GMP (Belgium),EU-GMP(Ireland), SAHPRA, Health Canada, EU-(Croatia), PIC/S Ukraine, US FDA, Uganda, Kenya, Tanzania, Kazak ,WHO-INDIA, etc