Durgakumar Kollepara

Background

About Durgakumar Kollepara

A highly motivated, result oriented Quality professional with 14+ years of diversified background experience in CSV, QC & QA areas of expertise include all aspects of quality and compliance for systems, process, facilities and operations for sterile and non sterile pharmaceutical manufacturing industries. • Strong knowledge in 21 CFR Part 11, EU Annexure 11, GAMP 5, Data integrity and ALCOA principles. • Excellent experience of reviewing URS, FS, QRM, CDS, SHA, SOP, IQ, OQ and PQ Protocols • Reviewed and validated Computerized Systems in compliance with 21 CFR Part 11 and EU annexure11. • Abundant experience in generating and reviewing Computerized Systems Validation (CSV) Deliverable phases according to 21 CFR Part 11 and FDA regulations. • Excellent Knowledge and experience in Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP). • Good Experience in preparation of Software Documentation, User Requirement Specifications, Risk assessment, traceability matrix, spreadsheet validation and Test Protocol documents. • Subject Matter Expert (SME) for computerized system validation of Process, Laboratory analytical equipment qualifications and spreadsheet validation for regulatory audits. • Familiar with Quality management systems like change management process, Risk assessment process & tools, Investigation and CAPA etc. • Manages own time to meet objectives, forecasts and plan resource requirements (people, financial and technology) for projects across department.