VENKATA NARAYANA NARU
Nellore
Summary
Technical Lead with 7 years of expertise in Computerized System Validation and regulatory compliance. Demonstrated success in orchestrating GxP projects and conducting thorough risk assessments. Proficient in cultivating collaboration and enhancing quality improvements, ensuring strict adherence to GMP and GAMP standards while achieving outstanding results.
Overview
16
16
years of professional experience
Work History
Technical Lead
HCL Technologies
Bangalore
02.2023 - Current
- Responsible for preparing and/or reviewing all levels of CSV validation documents including:
- Reviewing High-level Risk Assessments, which encompass GxP assessments, GAMP categorization, Criticality Assessment, and Electronic Records/Electronic Signatures (ERES) applicability assessment.
- Defining documents such as Functional Specifications, Design Specifications, Configuration Documents, Standard Operating Procedures (SOPs), Validation Master Plans (VMP), and Validation Protocols (VP).
- Creating Qualification Documents and Test Specifications (Design Qualification (DQ), Installation Qualification (IQ), and Operational Qualification (OQ) scripts).
- Developing Traceability Matrices, Gap Assessments, and Risk Analysis.
- Conducting 21 CFR Part 11 and EU Annex 11 assessments for process systems.
- Handling Validation Reports, Change Controls, Events, Deviations, and Defects.
- Providing CSV technical sign-off for all the aforementioned documents.
- Experience in various Software Development Life Cycle (SDLC) models, including Waterfall, V-Model, and Agile methodology.
- Involvement as a Validation Specialist in reviewing test scripts for IQ, OQ, and Performance Qualification (PQ).
- Providing guidance and support to internal teams for preparation and compliance with external and regulatory audits.
- Proficient in tools and systems such as ServiceNow, Jira, Confluence, Track wise.
Deputy Manager (Quality Assurance)
Aurobindo Pharma Private Limited
Nellore
01.2015 - 10.2022
- Proficient in preparing, reviewing, and approving documents.
- Possesses expertise in all phases of software and computer system validation in accordance with 21 CFR Part 11 and FDA GxP regulations.
- Managed Computer System Validation projects for GxP applications, ensuring compliance with regulatory standards such as USFDA, 21 CFR Part 11, EU Annex 11, ICH, and GAMP guidance.
- Conducted GxP assessments and data integrity evaluations.
- Ensured adherence to Good Manufacturing Practice (GMP), Good Engineering Practice (GEP), and GAMP guidelines in pharmaceutical manufacturing, with an emphasis on digitalization across production activities.
- Participated in investigations for deviations, customer complaints, and equipment/system failures, ensuring appropriate corrective actions were implemented.
- Performed risk-based assessments/approaches for compliant GxP computerized systems.
- Reviewed User Requirement Specification (URS) and Design Specification (DQ) documents.
- Periodically reviewed user management records.
- Qualified internal auditor for Quality systems, Production systems, Material systems, and Packaging and Labelling systems, performing Adhoc and Internal audits as per GxP standards.
Reviewer-II (Quality Assurance)
Apotex Research Private Limited
Bangalore
05.2011 - 10.2014
- Maintained quality systems, including Change Control, Deviation Control, Control of Nonconforming products, CAPA, Investigations, Documentation Control, and Training.
- Handled Quality Risk Management (QRM).
- Managed Market Complaints, Recalls, and Field Alert Reports (FAR).
- Collected and prepared data for monthly Review meetings and Quality Risk Management using QMS Software (Dash board - Metric Stream).
- Prepared key metrics to measure the Data Quality Index.
- Reviewed Quality Agreements.
Executive (Quality Assurance)
Kemwell Biopharma Private Limited
Bangalore
08.2009 - 04.2011
- Reviewed Process Validation Protocols.
- Reported non-conformances in the manufacturing area.
- Reviewed Batch Manufacturing and Packing records.
- Conducted In-Process Quality Assurance (IPQA) rounds.
- Monitored and supported commercial manufacturing and packing activities.
- Monitored production activities and coordinated with production personnel to fulfill documentation requirements.
Education
M.Sc -
Sri Venkateswara University, Sri Krishna Chaitanya Degree & PG College
Nellore, A.P01.2009
B.Sc -
Rao's Degree & PG College
Nellore, A.P01.2007
Skills
- Computerized System Validation
- Manufacturing Execution System
- E BMR Implementation
- Equipment Qualification
- Quality Management System
- GMP/GAMP
- SAP QM, MM module
- Regulatory Compliance
- Investigations
- Internal Audit
- Argus Drug Safety Data Base System
Languages
- Telugu
- Kannada
- English
- Hindi
Personal Information
Date of Birth: 07/01/85
Accomplishments
- Spearheaded the technical specialization in the creation of a new manufacturing facility in Nellore, demonstrating expertise in project management.
- Played a pivotal role in accompanying customer audits and successfully navigating over 17 regulatory audits, including USFDA, EUGMP, TGA, WHO, and other customer audits.
Disclaimer
I hereby declare that the above information is correct and true to my knowledge.
Timeline
Technical Lead
HCL Technologies
02.2023 - Current
Deputy Manager (Quality Assurance)
Aurobindo Pharma Private Limited
01.2015 - 10.2022
Reviewer-II (Quality Assurance)
Apotex Research Private Limited
05.2011 - 10.2014
Executive (Quality Assurance)
Kemwell Biopharma Private Limited
08.2009 - 04.2011
M.Sc -
Sri Venkateswara University, Sri Krishna Chaitanya Degree & PG College
B.Sc -
Rao's Degree & PG College