Raaga Ravali Tenneti

Quality Assurance Chemist @Sciegen Pharmaceuticals Inc

Hauppauge, NY, US

Evaluate and process observations, trends, or deviations to determine root cause(s) and assess the quality impact• Recommend CAPAs and ensure CAPAs implemented are effective.• Auditing systems, processes, and results and performing trend analysis and preparation of Annual Review of drug product quality (APQR) for all the drug products.• Maintenance and Archival of regulatory documents• Handling OOT/OOS investigations, investigations related to potential quality issues and/or deviations from standards.• Review Deviations and Non- conformances and collaborate with cross-functional team members• Complete risk assessments on vendor management activities• Strong knowledge of FDA and ICH guidance documents and GxP regulations• Review and approve raw material, packaging material, and finished product specification packages• Responsible for in-process checks and assurance during dispensing, Manufacturing, and Packaging operations• Schedule and conduct internal quality audits, issuance, and reconciliation of stability samples• Compilation of stability data for all drug products and review of stability protocols• Prepare and review monthly trends for stability chambers• Review and approval of Batch Manufacturing Records and Batch Packaging Records

Rajiv Gandhi University of Health Sciences

Doctor of Pharmacy - PharmD, Pharmacy

Northeastern University

Master's degree, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs