Niveditha Hegde
Quality Assurance
Bengaluru
Summary
Highly dedicated and results-oriented Quality Assurance Executive with over 6 years of experience in the pharmaceutical industry. Proven expertise in ensuring the quality and compliance of processes through meticulous testing, data analysis, and interpretation. Adept at driving continuous Improvement and maintaining the highest standards of product quality and regulatory compliance.
Overview
6
6
years of professional experience
4
4
Languages
Work History
Senior Executive (Quality Assurance)
Syngene International ltd
07.2024 - Current
- Documentation Management: Proficient in overseeing online documentation systems in alignment with Good Documentation Practices (GDP).
- Protocol & Report Review: Authorized to evaluate and approve protocols and reports for Method Validation, Method Verification, Method Transfers, Studies, and Compounding Stability.
- Analytical Records Oversight: Experienced in reviewing and approving analytical records including blank ODS, executed ODS, summary sheets, specifications, test results, and analyst qualification data.
- QMS Management via TrackWise: Responsible for reviewing Incident Management records and initiating, reviewing, and closing Change Control processes within the TrackWise Quality Management System, ensuring compliance with regulatory and organizational requirements.
- cGMP Compliance: Ensure adherence to current Good Manufacturing Practices (cGMP) across QA and QC functions.
- QC Team Supervision: Lead and coordinate daily operations of the Quality Control (QC) team to maintain operational efficiency and regulatory compliance.
- Instrument & Equipment Qualification: Approve qualification and calibration records for laboratory instruments and equipment.
- Audit Trail Review: Conduct and authorize periodic audit trail verifications in compliance with regulatory standards.
- Quality Assurance Documentation: Support the development, review, and implementation of quality assurance procedures.
- Cross-Functional Team (CFT) Procedures: Review and approve procedures related to quality control and cross-functional team activities.
- SOP Review & Revision: Responsible for reviewing Standard Operating Procedures (SOPs) and implementing necessary updates or corrections to ensure accuracy, clarity, and alignment with current quality and regulatory requirements.
Senior Scientist (Quality Control)
Anthem Biosciences Pvt. Ltd
10.2019 - 06.2024
- Method Validation: Experienced in validating analytical methods for detecting and quantifying compounds across diverse matrices.
- Routine Experimental Analysis: Conducted daily testing of raw materials, intermediates, and finished active pharmaceutical ingredients (APIs).
- Data Analysis & Interpretation: Proficient in analyzing complex data sets and drawing insights using MS Excel.
- Laboratory Techniques: Skilled in sample preparation, extraction, purification, and a wide range of laboratory procedures.
- Documentation & Reporting: Competent in technical report writing and documentation in line with ALCOA++ principles; adept at protocol development using MS Word.
- Regulatory & GxP Compliance: Thorough understanding of regulatory expectations for analytical methods; ensure strict adherence to GxP guidelines.
- Analytical Troubleshooting: Capable of identifying and resolving technical issues related to analytical instrumentation and methodologies.
- Cross-Functional Collaboration: Effectively coordinate with cross-disciplinary teams including QA, AR&D, R&D, and EHS to drive operational excellence.
Education
Master of Science - Organic Chemistry
Manipal University
Udupi, India 04.2001 -
Bachelor of Science - Chemistry
Mangalore University
Udupi, India 04.2001 -
Skills
Communication
Critical Thinking
Problem Solving
Adaptability
Time Management
Chromeleon
Empower
Lab X
MS Excel
MS Word
MS PowerPoint
LinkedIn Profile Link
https://www.linkedin.com/in/niveditha-hegde-0b53a616a
Instruments Used
- HPLC (PDA, VWD, and ELSD)
- UPLC (CAD)
- GC (ALS and HS)
- FT-IR
- Karl Fischer Titrator
- UV-Vis
Timeline
Senior Executive (Quality Assurance)
Syngene International ltd
07.2024 - Current
Senior Scientist (Quality Control)
Anthem Biosciences Pvt. Ltd
10.2019 - 06.2024
Master of Science - Organic Chemistry
Manipal University
04.2001 -
Bachelor of Science - Chemistry
Mangalore University
04.2001 -
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