Gowhar Raja Vandanapu

Senior Manager @Natco Pharma

Hyderabad, IN

Led the management and resolution of product quality complaints (PQC\'s) for pharmaceutical products, ensuring strict adherence to FDA andEuropean regulations while enhancing overall product safety and efficacy.Directed cross-functional teams to conduct thorough investigations of product quality complaints, adeptly identifying root causes andproposing impactful process improvements to drive service delivery excellence.Oversaw the comprehensive evaluation and approval of product complaints, ensuring swift resolutions that maintain high standards of servicequality and compliance with regulatory requirements.Participated actively in internal and regulatory audits, delivering compliance oversight for complaint management processes and qualitydocumentation, thereby supporting continuous adherence to industry regulations.Evaluated and approved Corrective and Preventive Actions (CAPA) proposed by cross-functional teams, guaranteeing effectiveness and timely execution to prevent recurrence of complaints and product quality issues.Coordinated the submission of field alert reports (FAR) to the US FDA and rapid alerts for European markets, ensuring prompt communication of critical product quality issues to the relevant stakeholders.Communicated critical market complaints and trending data during quality review meetings, effectively escalating issues to management and fostering a culture of proactive risk management.Developed and delivered comprehensive training programs on incident, deviation, and complaint handling procedures to various stakeholders,instilling a compliant quality culture across the organization.Monitored and reported on the status of open deviations and CAPAs to senior management, ensuring strict adherence to timelines andeffective resolution strategies for quality issues.Reviewed and approved changes in manufacturing processes and controlled documents, aligning them with regulatory requirements and operational necessities to enhance compliance.

Institute of Pharmaceutical Technology (Annamalai University)

M.Pharmacy (Quality Assurance)