Himansu Sekhar Dash
Hyderabad
Summary
Dynamic Validation Specialist with a proven track record at Eugia Pharma Specialties, mastering CQV and CSV protocols to ensure GxP compliance and FDA adherence. Excelled in leading cross-functional teams, showcasing exceptional project management and technical documentation skills. Achieved significant improvements in equipment reliability and regulatory compliance, underpinning successful product launches and training programs.
Overview
10
10
years of professional experience
Work History
Validation Specialist
Eugia pharma specialties
09.2021 - Current
- Led and executed CQV protocols (URS, FAT, SAT, IQ, OQ, PQ, RQ) for critical pharmaceutical and biopharmaceutical equipment, ensuring successful project delivery and compliance with regulatory standards.
- Developed and managed CSV protocols for GxP systems, adhering to FDA requirements, 21 CFR Part 11, and industry guidelines to ensure robust data integrity, electronic records management, and software compliance.
- Managed creation of Validation Master Plans, impact assessments, traceability matrices, and Validation Summary Reports (VSR).
- Prepared and reviewed CSV lifecycle documentation, including VMP, URS, HLRA, DQ/FS (HDS/SDS), ERES assessments, IQ, OQ, VA, VP, FRA, TM, VSR, PR, and summary reports, ensuring compliance with quality standards and regulatory requirements.
- Collaborated with cross-functional teams and external vendors, effectively coordinating project timelines, resolving issues, and ensuring the quality of equipment and systems.
- Conducted root cause analyses and implemented corrective actions (CAPA) for validation discrepancies, enhancing reliability, and ensuring compliance across equipment and systems.
- Prepared and executed process validation and cleaning validation protocols, aligning with industry best practices and regulatory guidelines for quality assurance.
- Directed training programs for junior engineers on CQV and CSV processes.
- Supported regulatory submissions and audit preparations by ensuring thorough documentation, validation strategy alignment, and compliance with industry standards, contributing to successful product launches.
- Investigated equipment failures, identified causes and initiated methods to resolve such issues.
Validation Engineer
Aurobindo Pharma Ltd
07.2014 - 08.2021
- Provided technical support in the development of test plans, protocols, reports, and SOPs.
- Prepared traceability matrices to ensure the traceability of system components.
- Created and executed CQV protocols (URS, FAT, SAT, IQ, OQ, PQ, RQ) for various equipment, including washing machines, lyophilizers, steam sterilizers, HVAC systems, and more.
- Prepared and reviewed CSV lifecycle documentation, including VMP, URS, HLRA, DQ/FS (HDS/SDS), ERES assessments, IQ, OQ, VA, VP, FRA, TM, VSR, PR, and summary reports, ensuring compliance with quality standards and regulatory requirements.
- Reviewed engineering drawings and specifications for accuracy in validation documentation.
- Assisted with the development of user requirement specifications.
- Evaluated vendor qualifications and performance against customer requirements.
- Validated software applications related to manufacturing operations.
- Maintained accurate records of all tests performed throughout the entire life cycle of a product or system.
- Ensured proper implementation of change control procedures when needed.
- Investigated equipment failures, identified causes and initiated methods to resolve such issues.
- Provided continuous process improvement, and preventive and corrective actions to facilitate operational efficiency.
- Prepared and reviewed validation protocols, including process and cleaning validation, ensuring regulatory compliance.
- Maintained comprehensive validation documentation and provided training to junior engineers.
- Conducted CSV projects for GxP systems, meeting FDA criteria.
Education
Master of Business Administration - TQM
Sikkim Manipal University
12.2014
Bachelor of Science - MECS
Osmania University
12.2011
Skills
- Commissioning, Qualification, Validation (CQV)
- Computerized System Validation (CSV)
- User Requirements Specifications (URS)
- Functional Requirements Specifications (FRS)
- System Development Life Cycle (SDLC)
- Validation Master Plans (VMP)
- Risk Assessment
- GxP Compliance, GAMP5, Critical assessment
- 21 CFR Part 11/ERES
- Validation Planning
- Project Management
- Technical Documentation
- Team Leadership and Training
- Continuous Improvement
- Good Manufacturing Practices (GMP)
- Regulatory Compliance (FDA, EMA, etc)
- Protocol Development (URS, FAT, SAT, DQ, IQ, OQ, PQ)
- Manufacturing operations
- Time management abilities
Awards
TOM-Five time received
Languages
- English (fluent)
- Hindi (fluent)
- Telugu (fluent)
Projects
- CSV Project for Manufacturing Systems and software applications
- Developed and executed CSV protocols, including risk assessments and validation scripts, ensuring compliance with FDA 21 CFR Part 11. Successfully achieved regulatory alignment for system integrity.
- End-to-End CQV for Critical Utilities
- Led CQV activities for cleanrooms, HVAC systems, water systems, and other critical utilities, ensuring compliance with cGMP and industry standards. Reduced validation deviations by 20% through meticulous protocol execution and vendor collaboration.
- Commissioning of Automated Filling and Packaging Equipment
- Managed and executed IQ/OQ/PQ protocols for high-speed filling and sealing machines, maintaining documentation for regulatory review and achieving validation milestones ahead of schedule.
Technical Skills
- Validation and Documentation:URS, FAT, SAT, IQ, OQ, PQ, HLRA, RTM, VSR, risk assessments
- Compliance Knowledge: FDA 21 CFR Part 11, GxP, cGMP, ISPE,ISO standards, data integrity practices
- Software and Tools :Microsoft Office, LIMS, eLog,eSop,project management software, quality control systems
Key Equipment and Systems Experience
- Pharmaceutical and Biopharmaceutical Equipment: Washing Machines, Depyrogenation Tunnels, Filling Machines, Sealing Machines, Lyophilizers, Packaging systems,Steam Sterilizers, HVAC Systems, Isolators, Mixing Vessels, CIP and SIP Skids, Reactors, Netzsch Mill, Dynomil, Homogenizers, and more.
- Controlled Environments: Cleanrooms, Dry Fogging Systems, Glove Integrity Systems, Walk-in Incubators, Humidity and Cooling Chambers, Deep Freezers, and Ultra Low-Temperature Freezers.
- Computer Systems and Software: GxP systems, LIMS, Elog,Esop,CMS,DSRS,CLEEN,HKMS, ERP systems, and quality management software.
Certifications
- CQV Specialist-PV,EQ,IQ,OQ,PQ by Udemy course.
- Certified Computer System Validation (CSV) Professional by Skillbee
Timeline
Validation Specialist
Eugia pharma specialties
09.2021 - Current
Validation Engineer
Aurobindo Pharma Ltd
07.2014 - 08.2021
Master of Business Administration - TQM
Sikkim Manipal University
Bachelor of Science - MECS
Osmania University
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