ROHIT MISHRA
Hamilton,Canada
Summary
Results-driven Quality Scientist with 12+ years of experience in Quality Control and Quality Assurance across global pharmaceutical organizations. Expert in analytical testing, quality management systems, root cause analysis and CAPA, and regulatory compliance (Health Canada, US FDA). Combines strong scientific reasoning and data analysis skills to ensure compliance, product excellence and continuous improvement. Recognized for leading cross-functional teams, mentoring analysts and implementing process improvements. Adept at adapting to dynamic environments and regulatory landscapes.
Overview
14
14
years of professional experience
Work History
Quality Control Scientist
Kenvue
Guelph, ON
06.2023 - Current
- Conduct comprehensive reviews of analytical documents and laboratory reports, ensuring accuracy, consistency and compliance with regulatory standards
- Review and approve raw material and finished product data in SAP, verifying alignment with product specifications and Health Canada/FDA requirements
- Validate data integrity and perform in-depth analysis of analytical results to identify trends and deviations, driving data-based decision-making
- Guide and mentor laboratory analysts on GLP and SOPs; provide regular feedback and technical training
- Lead the successful transition of testing methods (e.g., dissolution to disintegration), optimizing efficiency while maintaining regulatory compliance
- Prepare and maintain Laboratory Investigation Report (LIR) trending data; analyze trends to generate actionable insights for quality improvement
- Develop detailed job aids and training materials for laboratory instruments to promote consistent and accurate usage
- Support internal and external audits (Health Canada and US FDA) by ensuring audit readiness, executing corrective actions and collaborating across functions to maintain compliance.
Quality Assurance – Senior Associate
Endo India Pvt. Ltd
Indore
05.2021 - 04.2023
- Conducted root cause analysis for incidents, Out-of-Specification (OOS), Out-of-Trend (OOT) and extraneous peak events using QMS tools; documented findings and implemented CAPA.
- Collaborated with cross-functional teams to investigate quality issues, gather relevant data and drive timely closure of investigations.
- Reviewed and approved CAPA and change control requests; monitored implementation status and effectiveness.
- Reviewed analytical documentation for raw materials, finished products and stability studies to ensure accuracy and compliance.
- Compiled and analyzed QMS trend reports on incidents, OOS, OOT and CAPA to identify recurring issues and recommend process improvements.
- Prepared and updated SOPs for laboratory and quality control procedures to align with current regulatory requirements.
- Conducted monthly laboratory walkthroughs to ensure adherence to SOPs and Good Manufacturing Practices (GMP).
- Supported regulatory audits by ensuring audit readiness, verifying documentation accuracy and reviewing audit trail verification reports in Empower and other systems.
- Reviewed and verified IQ/OQ/PQ documentation for laboratory instruments.
Quality Control – Senior Officer
Glenmark Pharmaceuticals Ltd
Indore
05.2016 - 05.2021
- Participated in investigations of OOS, OOT, incidents and extraneous peaks; identified root causes and prepared comprehensive analytical variance reports.
- Developed and revised SOPs for routine laboratory procedures to ensure compliance with evolving regulatory standards.
- Processed chromatographic data for quantitative analyses; ensured data integrity, accuracy and compliance with test standards.
- Conducted quantitative analyses of formulated products, including assay, dissolution, content uniformity and related substances testing.
- Collaborated with QC leads and managers to meet test schedules and supported audit responses by addressing observations effectively.
- Mentored junior chemists and promoted compliance with cGMP and laboratory best practices.
Quality Control – Senior Officer
Sun Pharmaceuticals Ltd
Dewas
06.2011 - 01.2016
- Performed routine calibration of critical laboratory instruments including HPLC, GC, UV-Spectrophotometers
- Dissolution Apparatus and Infrared Spectrometers, ensuring compliance with established protocols
- Calibrated and qualified standalone instruments such as disintegration testers, tap density apparatus and viscometers
- Prepared reagents and performed standardization of volumetric solutions for laboratory testing
- Executed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for new instruments and re-qualified existing instruments
- Maintained calibration and qualification programs; prepared monthly and annual calibration planners and ensured adherence to schedules
- Trained and mentored chemists on cGMP requirements, SOP updates and calibration practices to enhance compliance and skill development.
Education
Bachelor of Science - Pharmaceutical Science
RGPV University
Bhopal, India06.2011
Bachelor of Science - Pharmaceutical Sciences
MIT College
Ujjain, India04.2008
Skills
- Quality Management Systems (QMS)
- Root Cause Analysis (RCA) & CAPA
- Regulatory Compliance (Health Canada, US FDA)
- Analytical Data Review & Data Integrity
- Data Analysis & Representation (trend analysis, statistical analysis, visualisation)
- Good Laboratory Practices (GLP) & GMP
- Team Leadership & Mentorship
- Technical & Regulatory Writing
- Process Improvement & Continuous Improvement
- Problem Solving & Critical Thinking
ADDITIONAL INFORMATION
- Instruments: HPLC (Waters Empower 3), GC (Perkin Elmer & Agilent), Differential Scanning Calorimetry, Thermogravimetric Analysis, UV-Spectrophotometer, Infrared-Spectrophotometer, Dissolution testing apparatus.
- Tools: Microsoft Office, SAP, LIMS, LES, Empower, TrackWise, MasterControl.
Accomplishments
- Spot Awards for error-free analysis (three consecutive times).
- 5-Star ratings in annual assessments for error-free analysis and achieving turnaround time (FY 2016) and for error-free chromatography (FY 2018).
- Gold Tier Award (President’s Club) – Glenmark Pharmaceuticals Ltd. (FY 2018–2019).
Timeline
Quality Control Scientist
Kenvue
06.2023 - Current
Quality Assurance – Senior Associate
Endo India Pvt. Ltd
05.2021 - 04.2023
Quality Control – Senior Officer
Glenmark Pharmaceuticals Ltd
05.2016 - 05.2021
Quality Control – Senior Officer
Sun Pharmaceuticals Ltd
06.2011 - 01.2016
Bachelor of Science - Pharmaceutical Science
RGPV University
Bachelor of Science - Pharmaceutical Sciences
MIT College
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