Apoorva Gosika

Associate Quality Content Specialist @Novartis

Hyderabad, IN

Verify source data and identify inaccuracies in clinical or preclinical study reports to ensure data integrity.• Conduct thorough reviews of (100%) factual statements, numeric data, and citations against source documents.• Support cross-divisional quality initiatives and contribute to accuracy in Clinical Study Reports and related documents.• Initiate and manage quality records; participate in process and quality improvement projects.• Communicate with cross-functional teams to maintain quality and compliance standards.• Prepare and review SOPs and GMP/GDP documentation to ensure regulatory compliance.• Oversee Regulatory Writing Services deliverables, manage QC processes, and review key reports for assigned projects.• Coordinate timelines for deliverables and ensure submission deadlines are met.• Serve as QC Coordinator/Lead, consolidating feedback and supporting writers and reviewers.• Utilize tracking tools to generate compliance metrics and monitor progress.