Durgakumar Kollepara

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.

Experience

1. Associate Manager

   辉瑞

   Jan 2013 — Present · Visakhapatnam, IN

   Validate and Implementation of CSV deliverables phases for Laboratory and Process equipment in accordance with GMP and regulatory (21 CFR & EU Annexure 11) requirements.• Preparation of Validation documents URS, DQ, PVP,CDS, IQ, OQ, PQ, cGMP Impact, GxP risk assessment, GAMP category, Software Risk Analysis, Summary report and ER ES assessments for computerized systems.• Preparation of Spreadsheet Category, GxP assessment and Validation protocols.• Subject Matter Expert (SME) for Computerized system validation, spreadsheet validation and analytical laboratory equipment. • Attending in deviations, investigations to identify root cause and define corrective and preventive actions (CAPA).• Review, approval & closure of change controls and deviations.• Good exposure in Empower server qualification. • Coordinate cross functional department for complies the documents & to meet the timlines,• Hands on Experience and knowledge on critical software validation for laboratory and process equipment as per 21 CFR and regulatory guidelines: Empower server enterprise. Tiamo server and clients qualification. High performance liquid chromatography (Make: Water and Agilent with Empower 3 software) Ultra performance liquid chromatography (Water: Water) Gas chromatography (Make: Agilent) Atomic absorption spectrophotometer. Particle size analyzers. Particle measuring systems. Data acquisition systems. Ion chromatography systems. Total Organic Carbon analyzers.(Make: GE) Filter Integrity testers.

Education

• Andhra University

  Master of Science - MS, Biochemistry

  2005 — 2007

• Andhra University

  Bachelor of Science - BS, Biotechnology/Biochemistry/Microbiology

  2001 — 2004