Lakshmi Varanasi

An experienced goal-oriented and results-driven Quality Assurance (QA) professional with a strong clinical background (10+ years of critical care nursing) and biotech/pharmaceutical companies (19+ years) in managing quality systems worldwide.Areas of expertise include GCP, GLP, PV, and IT Quality and Compliance.Audits and Inspections:Experience in preparing risk-based annual audit plans to execute routine and for-cause audits to achieve QA goals and objectives. Collaborate with partners to raise CAPAs, perform root cause analysis and CAPA Effectiveness Check to meet regulatory guidelines.Coordinate and evaluate effective performance metrics in the Clinical Domain for inspection readiness activities and escalate events of critical compliance issues. Train and motivate cross-functional teams for health authority inspections on an international scale.Strategy Development and Risk Mitigation:Successfully conduct complex initiatives such as quality risk management and evaluation strategies in day-to-day activities.Implement Clinical QA policies and operating procedures as part of continuous improvement processes. Participate in the validation, migration and testing of global computerized systems including document management systems and other clinical development databases.Leadership and Oversight:Skillful in managing QA professionals, operational teams and stakeholders. Engage in professional development and extensive interaction with all levels of senior leadership as well as enhance talent development and mentoring of diverse teams. Foster a collaborative culture and adapt to the evolving landscape of Clinical Quality. Direct human and financial resources to ensure project support to remain within budget while maintaining timelines.COMMITTEES/SOCIETIES/PROFESSIONAL AFFILIATIONS: Drug Information Association (DIA)Regulatory Affairs Professional Society (RAPS)Society of Quality Assurance (SQA)International Society of Pharmaceutical Engineering (ISPE)