Shravya Dyavarishetty

Quality Assurance @ Cipla USA

About

As a Quality Assurance professional with 3 years of experience, I ensure compliance with GMP and GDP standards by managing and reviewing quality control logs, analytical data, and documentation. My expertise includes conducting data integrity gap analyses, collaborating with cross-functional teams to resolve deviations, and enhancing quality systems management to improve operational efficiency. With a strong focus on quality benchmarks, I facilitate the timely release of pharmaceutical lots while maintaining uncompromised quality standards. With a Master's degree from Northeastern University, I've honed my expertise in pharmacy policy and regulatory affairs, ensuring our operations align with both organizational and regulatory expectations. My commitment to quality is matched by my dedication to continuous learning and working alongside cross-functional teams. Our joint efforts in quality assurance analysis have fortified Cipla USA's reputation for excellence in pharmaceuticals. It is my ambition to further contribute to the industry's advancement, ensuring the well-being of communities through stringent quality standards.

Country

United States

City

New York City Metropolitan Area

Industry

Pharmaceuticals

Skill

GxP, U.S. Food and Drug Administration (FDA), Root Cause, Change Control, Documentation, Quality Assurance Analysis, Quality Assurance Standards, Presentations, Technical Documentation, 21 CFR, Global Regulatory Compliance, Product Quality, Microsoft Word, Clinical Trials, Communication, ICH, Regulatory Compliance, Regulatory Documentation, Standard Operating Procedure (SOP), Quality System

Experience

Quality Assurance

Cipla USA

2023-7 - Present · 3 yrs 3 mos

United States

• Review of Analytical documents. • Examining documentation, investigations, and reports thoroughly. • Completion of all documentation to the required standard (ALCOA+). • Ensure compliance with SOPs, policies & procedures as required by the organization and regulated bodies. • Collaborate with cross-functional departments (Regulatory, Quality control, Production) in reviewing all documents relating to the manufacturing, packing & analysis report before the product release and dispatch. • Review of documents of respective areas and logbooks for adequacy and completeness. • To coordinate technical audits of the quality control laboratory to determine the analytical quality systems are yielding the highest quality information and to ensure that the analytical instrumentation is functioning properly, and calibration & servicing is as per schedule. • Responsible for routine “Good Manufacturing Practices Auditing” of the formulation process, control & related areas. • Responsible for the review and approval of controlled documents. • To establish guidelines and procedures on cGMP & GLP – Standard Operating Procedures of overall Quality control & assurance activities. • Responsible for review of executed documents for compliance including logbooks, Batch manufacturing & packing records.