KANAKARAO KOPPULA
Hyderabad
Summary
Results-driven validation and FDA compliance professional with over 6 years of experience in Computer Systems Validation (CSV) and Computer System Assurance (CSA), plus 9 years in Quality Control within the life science sector. Proficient in IT Quality Assurance, utilizing risk- based approaches and SDLC methodologies like Waterfall, V-Model, and Agile to ensure compliance, data integrity, and system functionality. Committed to enhancing processes through AI and automation.
Overview
15
15
years of professional experience
Work History
Deputy Manager
Jodas Expoim Pvt LTD
HyderaBad
06.2024 - Current
· Validate the Computerized Systems as per the inhouse policies, GAMP 5 guidance and Part 11 regulations to ensure that the Computerized Systems are functioning as intended to meet business requirements and as per the predetermined specifications.
· Preparing CSV related SOPs like CSV, 21 CFR Part 11, Incident Management, Audit trails review.
· Conducted GxP review of validation deliverables like User requirement specifications, Functional design specifications, configuration documents, test scripts, test results.
· Active team member for validation analysis, preparing test protocols, test summary reports and validation summary reports in accordance with US FDA as well as local regulatory bodies.
· Documenting the findings and deviations occurred during script execution.
PROJECT DETAILS:
Name: DMS (Document Management System) CLIENT: Jodas Expoim Pvt Ltd.
Tools: Manual Testing.
DESCRIPTION: Document Management System (DMS) is usually a computerized system used to store, share, track and manage files or document. Some Systems include history tracking where a log of the where is the versions created and modified by different users is recorded. The term has some overlap with the concepts of content management systems. It is often viewed has a component of enterprise content management (ECM) systems and related to digital asset management, document imaging, workflow systems and record management systems.
Other projects: Empower3 Server (HPLC), Lab solutions (UV, FTIR), TOCL(TOC), Tiamo(KF)
Senior Executive
Aurobindo Pharma Ltd
HyderaBad
11.2013 - 05.2018
- Maintained AMC, PM, layouts and External Calibration Schedules and execution as per schedule; managed PNC’S, Risk Assessments, CAPA, Change controls and deviations.
Associate
Dr. Reddy’s Laboratories
HyderaBad
04.2010 - 11.2013
- Performed analytical testing for in process and Finished products based on pharmacopeia methods USP, EP, and JP and ISO standards.
Skills
- Extensive Regulatory Knowledge: Proficient in cGxP regulations and software lifecycle standards, including 21 CFR Part 11, EU Annex 11, and GAMP 5, with expertise in SDLC methodologies such as Waterfall, V-model and Agile
- Computer System Assurance (CSA): Skilled in implementing CSA, using risk based approaches to ensure compliance, enhance product quality, and maintain data integrity through efficient processes
- CSV Documentation Mastery: Experienced in preparing and reviewing validation documents, including Validation Plans, User Requirement Specifications (URS), IQ/OQ/PQ protocols, Requirements Traceability Matrix (RTM), and SOPs
- Infrastructure Qualification: Expertise in developing and managing infrastructure qualification documentation (QP, IS, IQ, RTM) to ensure system integrity and compliance
- Systems Validation Expertise: Proven track record in 21 CFR Part 11 and EU Annex 11 assessments for complex systems like CDS, EDMS, LIMS, DMS
- AI and Automation: Experienced in leveraging AI tools and technologies to enhance validation processes, ensuring smarter, data driven compliance
- Risk and Compliance Management: Proficient in handling Defect, Deviation, CAPA, and Change Control management, ensuring system integrity and ongoing compliance
- Advanced Validation Tools: Experienced with industry leading validation platforms such as HP ALM,, Val Genesis, and Service Now, to streamline validation activities
- Audit and Compliance Leadership: Skilled in managing audit readiness for internal and external reviews, ensuring alignment with regulatory agencies like the US FDA
- Audit Trail, Data Integrity, and compliance Expertise: Proficient in implementing robust audit trail systems to ensure compliance with 21 CFR Part 11 and EU Annex 11 regulations, while establishing data integrity frameworks that guarantee accuracy, completeness, and consistency of data throughout its lifecycle Experienced in leveraging electronic systems for effective e-compliance, managing electronic signatures, and controlling documentation Knowledgeable in risk-based approaches to identify and mitigate data integrity risks, ensuring the protection of critical data and alignment with regulatory requirements
Disclaimer
I solemnly declare the information mentioned herein is true and correct to the best of my beliefs.
Timeline
Deputy Manager
Jodas Expoim Pvt LTD
06.2024 - Current
Senior Executive
Aurobindo Pharma Ltd
11.2013 - 05.2018
Associate
Dr. Reddy’s Laboratories
04.2010 - 11.2013
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