Shrey Dabgar
Toronto,ON
Summary
Experienced Quality Control Officer with a strong background in pharmaceutical testing and regulatory compliance. Skilled in the use of analytical instrumentation and well-versed in cGMP and ICH guidelines. Demonstrated success in data analysis, quality assurance, and supporting thorough OOS investigations to ensure audit readiness and continuous improvement. Reliable and detail-oriented professional seeking a Quality Supervisor role to leverage technical expertise and interpersonal skills. Committed to maintaining high standards and identifying opportunities for system enhancement to drive operational excellence.
Overview
5
5
years of professional experience
Work History
Quality Control Officer
Zentiva Pharmaceutical Ltd.
08.2021 - 08.2023
- Conducted assay, dissolution, uniformity, and impurity profiling for solid oral dosage forms.
- Participated in developing internal SOPs, test procedures, and validation protocols and reports.
- Performed stability testing as per ICH guidelines to determine drug shelf life.
- Operated and calibrated HPLC, GC, UV-Vis, and Karl Fischer for routine quality analysis.
- Ensured GMP, FDA, and ICH Q2(R1) compliance during analytical method validation processes.
- Assisted in OOS investigations and performed detailed root cause analysis.
- Reviewed COAs and Batch Release Documents prior to final product approval.
- Prepared and revised SOPs, test methods, and laboratory protocols to maintain documentation standards.
- Ensured accurate documentation and traceability of lab data for audit readiness and regulatory compliance.
- Maintained controlled environments by following lab safety protocols and good laboratory practices (GLP).
- Coordinated with QA and production teams to address quality-related issues in real time.
Executive Analyst
Torrent Pharmaceutical Ltd.
07.2018 - 08.2021
- Conducted raw material, in-process, and finished product testing as per USP, BP, IP.
- Performed wet lab analysis ensuring accuracy and adherence to pharmacopoeia standards.
- Carried out daily calibration and verification of instruments, supporting internal quality audits.
- Reported analytical results using validated software tools, MS Excel, Outlook, and other documentation systems.
- Maintained and documented Good Laboratory Practices (GLP) for compliance with regulatory inspections.
- Analyzed raw materials and final products, including sensory checks for color, odor, and texture.
- Collaborated with regulatory teams to submit accurate 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 Tarsadia University
INDIA08.2020
Skills
- Analytical Instrumentation Expertise – Pharmaceutical Assay Analysis – Data Systems Administration for Chromatography – Analytical Reporting Skills – cGMP, ICH Guidelines, FDA & Health Canada Compliance – Wet laboratory chemistry – Wet laboratory testing – Deviation and Investigation Management
- Quality assurance
- Data interpretation
- Regulatory compliance
- Data analysis
Websites
Accomplishments
- Successfully completed GMP & Regulatory Compliance Training, ensuring adherence to global pharmaceutical quality standards.
- Validated HPLC and analytical methods, contributing to faster and more accurate lab results.
- Achieved Workplace Safety and WHMIS Certification, promoting a safe and compliant laboratory environment.
SOFTWARE
- Empower Lab Solutions
- Chameleon
- Ms Office
- Outlook
- Workday
- Ms excel MS excel
Timeline
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 Tarsadia University
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