Jhanvi Mahajan
Godhra
Summary
Dedicated pharmaceutical professional with comprehensive experience. Specializing in pharmaceutical quality systems, compliance, and regulatory standards, including ICH, GDP, and GLP. Adept at identifying and resolving quality issues to ensure adherence to regulatory guidelines. Proven track record as a collaborative team player with excellent communication, organizational, and analytical skills.
Overview
6
6
years of professional experience
Work History
Executive
Alembic pharmaceuticals limited
Vadodara
12.2024 - Current
- Ensured all laboratory activities comply with GMP/GLP, safety, and internal company guidelines.
- Participated in quality-related activities, including handling of Out of Calibration (OOC), Out of Specification (OOS), Out of Trend (OOT), laboratory incidents, deviations, change controls, and CAPA.
- Prepared and reviewed various quality documents such as study protocols/reports, QMS-related documents, LIRs, PIRs, OOS, and OOT reports.
- Tracked and monitored the status of investigations, CAPA, deviations, OOS, OOT, LIR, PIR, and related quality events.
- Conducted thorough laboratory investigations for OOS, OOT, LIR, PIR cases and supported root cause analysis.
- Planned and executed hypothesis/simulation studies as part of investigation processes.
- Maintained and adhered to systems supporting the Quality Control function to ensure data integrity and compliance.
- Monitored and enforced adherence to Good Laboratory Practices (GLP) across laboratory operations.
- Ensured continuous regulatory inspection readiness within the Quality Control laboratory.
- Oversaw laboratory operations to ensure compliance with Standard Operating Procedures (SOPs) and Good Practices (GPs).
- Handled all aspects of investigation management including PIR, LIR, OOS, OOT, CAPA, and deviation-related activities
SR. FORMULATION TECHNICIAN
THERMO FISHER SCIENTIFIC
WHITBY
05.2022 - 06.2024
- Manufactured dosage forms in strict compliance with master manufacturing directions and SOPs
- Ensured product quality by adhering to cGMP and Safety Policies
- Performed all necessary process documentation and SAP transactions efficiently
- Conducted equipment setups, cleanups, and wash-up procedures to maintain processing equipment
- Accurately filled and maintained batch documentation according to regulatory standards
- Performed in-process quality checks to ensure consistency with manufacturing protocols
- Improved batch processing timelines through process optimization and troubleshooting
- Resolved quality issues that delayed Deviation Reports, ensuring timely batch approvals
- Reviewed processing and packaging batch records, ensuring strict compliance with quality agreements and regulatory standards
- Collaborated with cross-functional teams to support key projects across Validation, Investigation, and Maintenance departments
- Contributed to process improvement by participating in 5S projects, hazard analysis, investigations, and implementing CAPAs, leading to enhanced operational efficiency
- Maintained accurate production documentation, ensuring traceability and regulatory compliance throughout the manufacturing process
- Ensured adherence to safety protocols and participated in internal audits, strengthening safety and compliance practices
- Led continuous improvement projects, driving significant operational efficiency gains
- Participated in root cause investigations, providing solutions to prevent recurring issues
- Oversaw the training of new technicians, fostering a skilled workforce aligned with organizational goals
MEDICAL LABORATORY TECHNICIAN
IDEXX LABORATORIES
MARKHAM
01.2022 - 05.2022
- Conducted diagnostic tests and analysis, ensuring timely delivery of laboratory results
- Maintained compliance with laboratory SOPs and safety standards
- Assisted in sample collection, preparation, and testing using advanced laboratory technology
- Performed data entry and management in laboratory information systems (LIMS)
- Ensured proper handling and disposal of hazardous materials
CUSTOMER SERVICE ASSOCIATE
AL PREMIUM FOOD MART
SCARBOROUGH
09.2019 - 01.2022
- Delivered high-level customer service by addressing inquiries and providing product guidance
- Developed training programs for employees, enhancing customer service skills
- Designed promotional materials, including flyers, to maximize product sales
- Assisted in managing customer complaints and feedback to improve service standards
Education
ADVANCED DIPLOMA - ADVANCED BIOTECHNOLOGY
CENTENNIAL COLLEGE
CANADA01.2021
BACHELOR OF SCIENCE - PHARMACY
BABARIA INSTITUTE OF PHARMACY
INDIA01.2018
Skills
- GCP
- ICH
- FDA
- GLP
- GMP
- SOP compliance
- Quality issue resolution
- MS Office
- Adobe Reader
- SAP
- HPLC
- GCMS
- ICP-AES
- Spectrophotometry
- Calibration
- Quality systems
- Material sampling
- Material analysis
- ISO 9001
- ISO 14001
- Process documentation
- CGMP compliance
- In-process checks
- HACCP
- Quality management
- Laboratory operations
- Change control
- Quality assurance
- CAPA management
- Root cause analysis
- Laboratory investigation
References
Available upon request
Languages
English
Beginner
A1
Timeline
Executive
Alembic pharmaceuticals limited
12.2024 - Current
SR. FORMULATION TECHNICIAN
THERMO FISHER SCIENTIFIC
05.2022 - 06.2024
MEDICAL LABORATORY TECHNICIAN
IDEXX LABORATORIES
01.2022 - 05.2022
CUSTOMER SERVICE ASSOCIATE
AL PREMIUM FOOD MART
09.2019 - 01.2022
ADVANCED DIPLOMA - ADVANCED BIOTECHNOLOGY
CENTENNIAL COLLEGE
BACHELOR OF SCIENCE - PHARMACY
BABARIA INSTITUTE OF PHARMACY