Kevin Patel
Ahmedabad
Summary
Quality control professional with extensive experience at Amneal Pharmaceuticals, specializing in data integrity governance and compliance. Proven ability to lead root cause analysis and implement sustainable corrective and preventive actions (CAPA). Skilled in analytical data review and team mentoring, ensuring audit readiness and adherence to regulatory standards.
Overview
14
14
years of professional experience
Work History
Assistant Manager – Quality Control
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad
12.2013 - Current
- Provide comprehensive oversight of QC laboratory activities in compliance with USFDA, cGMP, ALCOA++, and 21 CFR Part 11 requirements.
- Conduct an in-depth review of chromatographic data and Waters Empower CDS audit trails, including baseline integration, sequence integrity, manual integration justification, reprocessing history, and electronic data traceability.
- Lead and evaluate Phase I and Phase II investigations for OOS, OOT, anomalous analytical results, and laboratory incidents; drive rigorous RCA and sustainable CAPA implementation.
- Manage data integrity controls through periodic audit trail reviews and electronic data governance checks across computerized analytical systems.
- Serve as an Analyst/Reviewer SME during USFDA regulatory audits and customer inspections.
- Initially worked as an Analysis Planner, coordinating analytical testing of in-process, finished product, and stability samples, while closely coordinating with Production and QC teams to ensure timely sample release, smooth laboratory operations, and on-time completion and reporting of analytical results.
Executive – Quality Control
Alembic Pharmaceuticals Ltd.
Baroda
11.2012 - 12.2013
- Performed analytical testing of in-process, stability, and finished product samples in accordance with USP, EP, Ph. Eur.
- Operated HPLC using Empower/EzChrom software, AAS, UV-Vis spectrophotometers, dissolution testers, and Karl Fischer titrators.
- Maintained real-time, audit-ready laboratory records, raw data, worksheets, and instrument logbooks in accordance with GDP requirements.
- Supported laboratory troubleshooting, atypical result reporting, and routine preventive maintenance of chromatographic equipment.
Education
Master of Science (M.Sc.) - Chemistry
Sardar Patel University
Vallabh Vidyanagar05.2012
Bachelor of Science (B.Sc.) - Chemistry
M.B. Patel Science College
Anand05.2010
Skills
- Analytical troubleshooting and Data Review
- Data integrity governance, Audit readiness and compliance
- Out of specification, Out of Trend, and Laboratory incident oversight
- Team leadership
- Root cause analysis
- Stability program management
Regulatory Quality Focus
- CGMP
- 21 CFR Part 11
- Data Integrity / ALCOA+
- OOS/OOT and CAPA
- Deviation Management
- Change Control
- Audit Trail Review
Accomplishments
Employee of the Month Dec-2015
Timeline
Assistant Manager – Quality Control
Amneal Pharmaceuticals Pvt. Ltd.
12.2013 - Current
Executive – Quality Control
Alembic Pharmaceuticals Ltd.
11.2012 - 12.2013
Master of Science (M.Sc.) - Chemistry
Sardar Patel University
Bachelor of Science (B.Sc.) - Chemistry
M.B. Patel Science College