Madhavi Y
DFW Metroplex,TX
Summary
Compete in a stimulating and challenging environment while striving to be part of the organization's success and also continuously learn and utilize potential knowledge gained from my experience.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Computer System Validation (CSV) Consultant
SBS solutions
Remote
01.2023 - 04.2024
- Responsible of All Administration Activities for Manufacturing Equipment’s, CSV, and GxP System’s
- Classification of system based on GAMP 5 and Risk based approach to compliant GxP computerized system.
- Performing validation like GAP Assessments, Risk Assessment, GxP Assessment, OQ Test script EDC (Electronic data compliance based on 21 CFR part 11 & EU Annexure 11)
- Ability to execute Change control, System Classification/Software categorization/ Software sub categorization, System Criticality Assessment, ER-ES readiness, System URS, FS, DQ, Validation Plan, IO, OQ, PQ and Final ER-ES, Risk Assessment Closure, Required Traceability Matrix (RTM), Validation Summary Report (VSR) System Release Certificate
- Preparation of validation strategy, specification documents, risk assessment, test protocols and validation report
- Responsible for Periodic review categorization, Audit trail review, Privileges matrix, User Management, Updating Policy groups, Windows control, manual/auto backups
- Worked on Incidents, Risk Assessment, Investigations, Root Cause Analysis, CAPA, Gap Analysis, SOP, Computerized system inventory
- Responsible for Recipe Creations and Review
- Responsible review of Data flow required parameters of GxP system
- Preparation & Review of Installation Qualification (IQ) Operation Qualification document (OQ) & Performance Qualification (PQ) Protocols
- Review of Unit & Integration Testing Documentation
- Performed Periodic review for the validated system to determine re-qualification requirement
- Coordinate with the business/IT teams on the pre-audit documentation and facilitate internal/external audits
Validation Analyst Intern
Gvk Biosciences
07.2011 - 08.2014
- Expertise in Computer System Validation(CSV), Adequate knowledge on 21 CFR Part 11,EU Annex 11, GAMP 5, MHRA'S data integrity guidance and other GXP(GMP,GCP,GLP) regulations and Good Documentation Practices(GDP).
- Hand-on experience with GAMP-5 Guidelines.Knowledge of testing SDLC methodologies such as Waterfall, Agile and V model.
- Good knowledge in developing and documenting Validation Master Plan, Validation Summary Report (VSR), Requirement Traceability Matrix (RTM), Standard Operating Process(SOP).
- Experience in developing User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).Working knowledge in developing, executing, and reviewing IQ,OQ,PQ test scripts, Risk Assessments, Gap Analysis and CAPA (Corrective Action and Preventive Action)Documents.
Customer Support Associate
HSBC Electronic Data Processing
Visakhapatnam, India
06.2008 - 03.2011
- Assisting HSBC customers across Middle East Countries through mail and phone as required and secure payments by providing them with various repayment options.
- Opportunity of working as an audit marshal, ensuring the team to strictly follow the audit compliance policies and procedures of the company.
- Lead the group with process knowledge and train new team members.
Education
Master of Science - Biotechnology And Human Genetics
Andhra University
Visakhapatnam, India04-2005
Skills
- Validation Regulations/Guidelines : 21 CFR Part 11, EU Annex 11, GAMP 5 Guidelines, GxP, GMP, GDP, GCP, GLP
- Validation Process: Validation Plan,Validation Report, User Requirement Specification, Design Qualification, Risk Assessment, IQ, OQ, PQ, Compliance Report, Audit trail, Data Integrity, CGMP Guidelines ,Risk assessment
- Revalidation,Qualification needs, Gap analysis, Deviations, Validation Summary Reports, Requirements Traceability Matrix, SOPs, Document Management system, CAPA, SDLC Methodologies, V-Model, MS Office, Word, Excel, Power Point
Certification
Attended Computer System Validation training for advanced and latest process knowledge
Languages
English
Professional
Hindi
Professional
Telugu
Native/ Bilingual
Timeline
Computer System Validation (CSV) Consultant
SBS solutions
01.2023 - 04.2024
Validation Analyst Intern
Gvk Biosciences
07.2011 - 08.2014
Customer Support Associate
HSBC Electronic Data Processing
06.2008 - 03.2011
Master of Science - Biotechnology And Human Genetics
Andhra University
Attended Computer System Validation training for advanced and latest process knowledge
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