HARSHANI JADAV
Greater Toronto Area,Canada
Summary
Detail-oriented Quality Control Officer with 2+ years of experience in pharmaceutical quality control and analytical testing. Expertise in GMP compliance, method validation, stability testing, and analytical instrumentation (HPLC, GC, UV, IR). Strong background in SOP adherence, documentation review, and regulatory compliance. Passionate about continuous learning and enhancing quality management systems.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Quality Control Executive (Documentation)
JB Pharmaceutical
Ankleshwar, GJ
08.2022 - 10.2023
- Reviewed and maintained quality control documentation including Certificates of Analysis (C of A), batch records, and stability reports
- Ensured compliance with GMP, GLP, and regulatory guidelines by properly documenting test results and analytical data
- Coordinated with laboratory analysts and quality assurance teams to ensure accurate documentation of analytical results
- Assisted in preparation and review of SOPs, method validation reports, and stability protocols
- Conducted data integrity checks to ensure accuracy and compliance with industry standards
- Supported regulatory inspections and audits by ensuring proper documentation management and retrieval
- Trained team members on best practices for documentation and data recording in compliance with pharmaceutical regulations
Quality Control Officer
JB Pharmaceutical
Ankleshwar, GJ
08.2021 - 07.2023
- Performed chemical and physical analysis of raw materials, intermediates, and finished products using HPLC, GC, UV, and IR spectroscopy
- Conducted stability testing to ensure product compliance with ICH guidelines
- Assisted in method validation, method transfer, and analytical method development to improve testing efficiency
- Ensured GMP and GLP compliance in all laboratory activities, minimizing deviations and maintaining quality standards
- Maintained laboratory documentation, Certificates of Analysis (C of A), stability reports, and logbooks
- Performed instrument calibration and troubleshooting to ensure smooth laboratory operations
- Collaborated with cross-functional teams for investigations, OOS (Out of Specification) results, and CAPA implementation
- Assisted in regulatory audits and inspections, ensuring proper documentation and compliance with regulatory standards
Education
PG.Dip - Pharmacovigilance, RA and Clinical Research
Academy of Applied pharmaceutical Sciences
North York, Toronto04.2025
Masters of Pharmacy - PHARMACEUTICS
Maliba Pharmacy College
Bardoli, India05.2021
Bachelors of Pharmacy -
Maliba Pharmacy College
Bardoli, India05.2019
Skills
- SOP Adherence
- GMP Compliance
- Stability Testing
- Method Validation
- Chemical Sampling
- Method transfer
- Analytical Calibration
- Certificate of Analysis
- Safety Compliance
- Documentation Review
- Data Management
- Computer literacy
- GMP
- GLP
- Physical testing
- HPLC
- GC
- IR
- UV
- Team Collaboration
- Communication skills
- Critical Thinking
Certification
- Good Manufacturing Practices Level I
- Introduction to Regulatory Affairs
- Global Regulatory Strategies
- The Canadian Pharmaceutical Industry: Big Picture
Timeline
Quality Control Executive (Documentation)
JB Pharmaceutical
08.2022 - 10.2023
Quality Control Officer
JB Pharmaceutical
08.2021 - 07.2023
PG.Dip - Pharmacovigilance, RA and Clinical Research
Academy of Applied pharmaceutical Sciences
Masters of Pharmacy - PHARMACEUTICS
Maliba Pharmacy College
Bachelors of Pharmacy -
Maliba Pharmacy College
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