Shrey Dabgar
Kitchener,ON
Summary
Results-driven professional with 5 years of experience in pharmaceutical analysis and compliance. Demonstrated expertise in analytical method validation, stability studies, and regulatory documentation. Skilled in operating HPLC, GC, UV-Vis Spectroscopy, FTIR, and dissolution apparatus. Extensive hands-on experience in raw material testing, finished product analysis, and impurity profiling. Well-versed in GMP, ICH guidelines, FDA, and Health Canada regulations. Currently enhancing regulatory abilities through a Postgraduate Certificate in Regulatory Affairs and planning to pursue a Postgraduate Certificate in Clinical Research by April 2025.
Overview
7
7
years of professional experience
Work History
Kitchen Assistant
Tamasha (Indian Bar & Kitchen)
09.2024 - Current
- Assisted chefs in food preparation tasks, resulting in timely meal service.
- Cleaned and organized kitchen stations to promote team efficiency.
- Collaborated with team members to ensure smooth workflow during peak hours.
- Provided backup support to other staff members during busy periods or staff shortages.
Crew Member
McDonald's
11.2023 - 10.2024
- Worked front counter, drive-thru and other areas.
- Took orders, prepared meals, and collected payments.
- Demonstrated strong multitasking abilities, handling multiple orders simultaneously without compromising quality or efficiency.
- Worked well with teammates and accepted coaching from management team.
Quality Control Officer
Zentiva Pharmaceutical Ltd.
08.2021 - 08.2023
- Conducted assay, dissolution, uniformity, and impurity profiling for solid oral dosage forms.
- Performed stability testing under ICH guidelines to assess drug shelf life.
- Operated and calibrated HPLC, GC, UV-Vis, and Karl Fischer titrations for routine analysis.
- Ensured compliance with GMP, FDA, and ICH Q2(R1) guidelines for analytical method validation
- Assisted in out-of-specification (OOS) investigations and root cause analysis.
- Reviewed Certificate of Analysis (COA) and Batch Release Documents before product approval.
- Prepared and revised Standard Operating Procedures (SOPs) and laboratory protocols.
Executive Analyst
Torrent Pharmaceutical Ltd.
07.2018 - 08.2021
- Conducted raw material, in-process, and finished product testing per pharmacopoeias standards (USP, BP, IP).
- Analyzed residual solvents, heavy metals, and microbial limits in pharmaceutical formulations.
- Performed forced degradation studies for stability-indicating methods.
- Documented and supported Good Laboratory Practices (GLP) records for regulatory audits.
- Aided in method transfer activities between R&D and production sites.
- Coordinated with regulatory teams to provide analytical data for drug master files (DMFs).
Education
Post-Graduate Certificate - Clinical Research
Conestoga College
Kitchener04-2025
Post-Graduate Certificate - Regulatory Affairs
Conestoga College
Kitchener, ON04-2024
Master of Science - Organic Chemistry
Uka Tarsadiya University
India06-2018
Bachelor of Science - Chemistry
The P G Science College
India05-2016
Skills
- Analytical Instrumentation Expertise
- cGMP, ICH Guidelines, FDA & Health Canada Compliance
- Pharmaceutical Assay Analysis
- Analytical Method Development
- Data Systems Administration for Chromatography
- Deviation and Investigation Management
- Analytical Reporting Skills
Accomplishments
• GMP & Regulatory Compliance Training
• HPLC & Analytical Method Validation
• Workplace Safety and WHMIS Certification
Languages
English
Full Professional
Hindi
Native or Bilingual
Gujarati
Native or Bilingual
Software
- Empower Lab Solutions
- Chameleon
- Ms Office
Timeline
Kitchen Assistant
Tamasha (Indian Bar & Kitchen)
09.2024 - Current
Crew Member
McDonald's
11.2023 - 10.2024
Quality Control Officer
Zentiva Pharmaceutical Ltd.
08.2021 - 08.2023
Executive Analyst
Torrent Pharmaceutical Ltd.
07.2018 - 08.2021
Post-Graduate Certificate - Clinical Research
Conestoga College
Post-Graduate Certificate - Regulatory Affairs
Conestoga College
Master of Science - Organic Chemistry
Uka Tarsadiya University
Bachelor of Science - Chemistry
The P G Science College
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