LIMS
J. Lalitha Kumari
Quality Assurance Professional
Vizianagaram
Summary
Strategic Quality Compliance with over 7 years of progressive experience in driving operational excellence through rigorous audit frameworks and process optimization. Proven track record in maintaining high-standard regulatory adherence across multiple chronological assignments. Expert in identifying systemic risks and implementing corrective actions that safeguard organizational integrity and product quality.
Overview
8
8
years of professional experience
1
1
Language
Work History
Quality Assurance-Site Investigation Team
Dr. Reddys Laboratories
06.2025 - Current
- Coordinate and review GMP/GLP works and documentations of Quality Management Systems.
- Analysis of Intermediates, Raw Material and API samples by HPLC and chemicals analysis (like FTIR, UV, SOR, WC, PSD by Malvern & ERH Analyzer etc.)
- Preparation and Control of Retention samples
- Preparation of Raw data work sheets of chemical analysis, GC analysis and HPLC analysis
- Knowledge in SIXSIGMA, LEAN SIX SIGMA and 5`s activity.
- Preparation and investigations of OOSs/OOTs and Deviation reports.
- Major Contributions
- Preparation and review of SOPs, Work Sheets and Analyst qualification/ Evaluation and on-job Training.
- Procurement of Reference standards and Qualification of Working Standards.
- Handling of customers and Regulatory inspections.
- Implementing the quality system with respect to regulatory and cGMP Requirements.
- Co-ordination and participation in internal audits.
- Handling of OOSs/OOTs Investigation and CAPA Implementations.
- Preparation of Analytical Method Validation and Analytical Method Transfer Protocols and Reports
- Prepare and summarize the Audit Reposes related to internal and external audits etc.
- Handling of Change control through Agile PLM system of Installation of new instruments like IQ, OQ and PQ. etc.
- Handling of Deviations through Agile PLM system
Quality Control-Quality Management system
Dr. Reddy’s Laboratories Ltd.
10.2023 - 06.2025
- Handling of investigations in co-ordination with QC and other departments.
- Handling of Incidents, Out of specifications, Out of Trend and deviations in Quality control
- Handling of Corrective and Preventive actions proposed out of investigations.
- Verification of implemented CAPAs and its effective checks.
- Preparation of SOPs and imparting training to team.
- Responsible for GEMBA walks and verification of compliance.
- Handling of SAP and LIMS.
- Participation in external trainings and leadership programs.
- Handling of Change Control Management
Quality Management system
Aurobindo Pharma Ltd. (APITORIA Pharma Private Ltd.)
07.2018 - 10.2023
- Coordinate and review GMP/GLP works and documentations of Quality Management Systems.
- Analysis of Intermediates, Raw Material and API samples by HPLC and chemicals analysis (like FTIR, UV, SOR, WC, PSD by Malvern & ERH Analyzer etc.)
- Preparation and Control of Retention samples
- Preparation of Raw data work sheets of chemical analysis, GC analysis and HPLC analysis
- Knowledge in SIXSIGMA, LEAN SIX SIGMA and 5`s activity.
- Preparation and investigations of OOSs/OOTs and Deviation reports.
- Major Contributions
- Preparation and review of SOPs, Work Sheets and Analyst qualification/ Evaluation and on-job Training.
- Procurement of Reference standards and Qualification of Working Standards.
- Handling of customers and Regulatory inspections.
- Implementing the quality system with respect to regulatory and cGMP Requirements.
- Co-ordination and participation in internal audits.
- Handling of OOSs/OOTs Investigation and CAPA Implementations.
- Preparation of Analytical Method Validation and Analytical Method Transfer Protocols and Reports
- Prepare and summarize the Audit Reposes related to internal and external audits etc.
- Handling of Change control through Agile PLM system of Installation of new instruments like IQ, OQ and PQ. etc.
- Handling of Deviations through Agile PLM system
Education
Master of Science - Chemistry
Andhra University
Visakhapatnam, Andhra Pradesh Skills
Investigation of OOS, OOT and Deviation
Expertise in investigation methodologies like Kepner Tregoe (KT), 5Whys, Fishbone (Ishikawa) and FMEA
Proposing and implementation of CAPA and verification of Effectiveness Check
Participation in Self-Inspections/Audits, Trainings and Compliance
Good Team Player, highly motivated and result oriented professional with Strong analytical and Team building skills and good documentation skills, confident, logical and follow timelines
Quick learner and maintain current up-to-date job knowledge & skills, Organized and well-Structured at work
Well-versed in operation, trouble shooting and maintenance of analytical techniques
Honest, Sincere and a hard worker with a high level of integrity
Declaration
I hereby declare that the information furnished above is true to the best of my knowledge. Date: Place: Vizianagaram (J. Lalitha Kumari)
Personal Profile
- NAME: J. Lalitha Kumari
- Father’s name: J. Ramamurthy
- Communication Address: D/O J. Ramamurthy Plot No.: 259, Gayatri Nagar IInd lane, Dharampuri, Vizianagaram AP. India 535002
Software
Empower
SAP
MS Office
DocHub
Timeline
Quality Assurance-Site Investigation Team
Dr. Reddys Laboratories
06.2025 - Current
Quality Control-Quality Management system
Dr. Reddy’s Laboratories Ltd.
10.2023 - 06.2025
Quality Management system
Aurobindo Pharma Ltd. (APITORIA Pharma Private Ltd.)
07.2018 - 10.2023
Master of Science - Chemistry
Andhra University