Padmini Thadipi
Process Validation Consultant
Bengaluru,Bengaluru
Summary
A Chemical Engineer with over 9 years of pharmaceutical industry experience in QA, CSV, Audits, Compliance, QMS, DMS, LIMS and regulations. Highly motivated, well organized and detail oriented.
Overview
10
10
years of professional experience
4
4
years of post-secondary education
2
2
Certifications
Work History
Process Validation Consultant
GalaxE Solutions Pvt Ltd an Endava Company
Bengaluru
06.2022 - Current
- Handled customer audits, regulatory inspections, audit reports, follow up with cross functional departments for audit response and sending out response to customer
- Successfully mitigated 94 percent of non-conformances during the validation phase, leading to improved production readiness
- Incorporated feedback from cross-functional teams to revise and implement robust Software Development Life Cycle (SDLC) Standard Operating Procedures (SOPs) and policies
- This resulted in streamlined processes and enhanced efficiency across the organization
- Reviewed CSV documents such as Validation Plan, Validation summary, test script, IQ, OQ and PQ as per SDLC, GAMP 5 and EU Annexure 11
- Upon successful validation and deployment, took responsibility for issuing validation certificates to customers, ensuring transparency and trust in the product’s quality and compliance
- Review and approval of CAPA, deviations and change control
- Quality Metrics Consolidation weekly, monthly and quarterly
- Providing required data for Management Review.
Assistant Manager
ALS Testing Services Pvt Ltd
Bengaluru
04.2019 - 06.2022
- Successfully handled various internal, customer, and regulatory audits, including US FDA audits, and achieved outstanding results with Zero 483 observations and NABL compliance
- Demonstrated expertise in successfully implementing applications such as Quality Management System (QMS), Document Management System(DMS), and training application Nichelon
- Additionally, assumed the role of administrator for these applications, showcasing exceptional technical proficiency and leadership capabilities
- Through effective implementation and administration, streamlined processes, improved data management,and enhanced training initiatives, contributing to increased overall efficiency and compliance within the organization
- Review and Approval of QMS Trending: Took charge of reviewing and approving Quality Management System (QMS) trending data, analyzing trends, and identifying potential areas for continuous improvement
- Conducting Management Review Meetings: Facilitated and conducted regular management review meetings, providing a platform for key stakeholders to discuss quality performance, identify areas for improvement, and strategize future quality objectives.
Scientist
Anthem Bioscience Pvt Ltd
Bengaluru
11.2017 - 04.2019
- Review of Analytical Method Validations and Reports: Meticulously reviewed and evaluated analytical method validations, cleaning validation, and method qualification reports, ensuring accuracy, compliance with established protocols, and adherence to regulatory requirement
- Comprehensive Review of Various Reports: Conducted thorough assessments of Finished Product, Intermediate, Raw Material, Stability reports, working standard reports, and In-process reports generated through Lab Solutions software and Empower-3 software via LIMS (Laboratory Information Management System)
- Coordination for Audit Preparations and Documentation: Led and coordinated efforts for audit preparations, compiling necessary documentation and ensuring compliance with audit requirements
- Efficiently managed Corrective and Preventive Action (CAPA) plans for addressing audit observations
- Active Participation in Regulatory Audits: Successfully participated in regulatory audits conducted by esteemed authorities such as USFDA, TGA, AbbVie, EA Pharma, and other customer audits.
Analyst
GVK Bioscience Pvt Limited
Bengaluru
03.2016 - 10.2017
- Conducting GLP Audits of Various Departments: Successfully conducted Good Laboratory Practice (GLP) audits of various departments within the organization
- Thoroughly assessed adherence to GLP principles, identified areas for improvement, and implemented Corrective and Preventive Actions (CAPAs) to address any identified non-compliances
- Preparation and Review of SOPs and Validation Protocols: Demonstrated proficiency in preparing and reviewing Standard Operating Procedures (SOPs) as well as Installation Qualification(IQ), Operational Qualification(OQ),and Performance Qualification (PQ) protocols and reports for instruments and equipment
- This contributed to standardized and compliant processes for instrument usage and maintenance
- Review and Approval of QMS Documents: Demonstrated a keen eye for detail in reviewing Quality Management System (QMS) documents, providing valuable feedback, and ensuring their approval
- This helped to establish an effective QMS framework that supports the organization’s commitment to maintaining high-quality standards.
Research Associate
ABC Industries Pvt Limited
Bellary
08.2012 - 08.2015
- Observe GLP and safe laboratory practices
- Maintaining all Calibration Schedule & AMC/Preventive maintenance Schedule
- Handling and maintaining of all training records
- Assist in Audits & preparation of Audit Compliance Reports
Education
Bachelor of Engineering (B.E.) - Chemical Engineering - undefined
Manipal University
06.2008 - 05.2012
Skills
QMS
Certification
CAPA Training, Data Integrity and its compliance requirements, 21 CFR Part 210, 211-cGMP USFDA, 2020, M/s. Pharma QA compliance services
Timeline
Process Validation Consultant
GalaxE Solutions Pvt Ltd an Endava Company
06.2022 - Current
Assistant Manager
ALS Testing Services Pvt Ltd
04.2019 - 06.2022
Scientist
Anthem Bioscience Pvt Ltd
11.2017 - 04.2019
Analyst
GVK Bioscience Pvt Limited
03.2016 - 10.2017
Research Associate
ABC Industries Pvt Limited
08.2012 - 08.2015
Bachelor of Engineering (B.E.) - Chemical Engineering - undefined
Manipal University
06.2008 - 05.2012
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