Sreelakshmi P J
Quality Assurance
Bangalore
Summary
As a skilled quality assurance professional with a background in chemistry, I bring a proven ability to ensure compliance, increase efficiency, and drive results. With expertise in quality management, auditing, and regulatory compliance, I have a track record of collaborating effectively with cross-functional teams to achieve common goals. My strong communication and problem-solving skills make me a valuable asset to any organization seeking to improve quality and streamline processes
Overview
2
2
year of professional experience
4
4
years of post-secondary education
3
3
Certificates
Work History
Executive, Quality Assurance
Biocon Biologics Ltd
Bangalore
11.2021 - Current
- Responsible for handling of Market Complaints, Quality Related Notifications and Corrective and Preventive Actions
- As part of complaint handling, conducted investigations, which involved reviewing batch records, verifying reserve samples, and investigating vendors, all while ensuring that complaints were addressed promptly.
- Ensured clear and accurate documentation of all investigative activities and results, and maintained proper file records in accordance with established procedures.
- Reviewed and approved the implementation of Corrective and Preventive Actions (CAPAs) across multiple departments, which involved risk assessments, procedural revisions, and evaluating the effectiveness of implemented actions.
- Independently faced audits and liaised for US FDA, EMA, ANVISA, INVIMA and other regulatory bodies.
- Ensured proper review and timely closure of Corrective and Preventive Actions (CAPAs) initiated as part of such audits or inspections.
- Effectively communicated complex technical information to cross-functional teams, regulatory bodies, and external stakeholders, resulting in successful resolution of numerous market complaints and timely closure of all related CAPAs
- Highly skilled in managing Quality Management System (QMS) elements within the TrackWise system.
- Possess expertise in conducting market complaint investigations and have the ability to analyze and resolve underlying issues related to drug products, medical devices, or combination products.
- Possess a comprehensive understanding of applicable regulations and guidelines, including those issued by the FDA, EMA, and ICH, and have a demonstrated ability to ensure compliance with these standards.
Education
Msc Chemistry - Chemistry
Jain University
Bangalore 06.2019 - 05.2021
Bsc Chemistry - Chemistry
St Josephs
Irinjalakkuda 04.2017 - 03.2019
Skills
Quality management
Research and analysis
Procedure implementation
Regulatory compliance
Data analysis
Laboratory techniques
Communication skill
Problem-solving skills
Attention to detail
Time management
MS Office and other tools
Certification
Biocon Ramaiah Certificate Program in Quality Control Analytical (8 weeks full time certification program)
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Computer System Valdation Certification from Global Institute of Regulatory Affairs
01-2024
Received Certificate of Appreciation as “Rising Star” for the contribution in supporting business continuity and functional goals (Half yearly Rewards and Recognition)
01-2023
Executive, Quality Assurance
Biocon Biologics Ltd
11.2021 - Current
Biocon Ramaiah Certificate Program in Quality Control Analytical (8 weeks full time certification program)
08-2021
Msc Chemistry - Chemistry
Jain University
06.2019 - 05.2021
Bsc Chemistry - Chemistry
St Josephs
04.2017 - 03.2019