Kabir Jethwa
Kitchener
Summary
Accomplished Quality Assurance Specialist with expertise in regulatory compliance and data analysis. At Zydus Pharmaceuticals, led audits and improved protocol efficiency, enhancing compliance and reducing deviations. Skilled in process improvement and collaboration, driving operational excellence and fostering team synergy. Proficient in technical documentation and SOP optimization, ensuring audit readiness and streamlined operations.
Overview
2023
2023
years of professional experience
Work History
Quality Assurance Specialist
zydus pharmaceuticals
Ahmedabad
12.2022 - 02.2023
- Conducted 25+ internal audits annually to identify non-conforming issues within facility and equipment validation processes, resulting in a 30% reduction in recurring deviations and improved audit readiness.
- Analyzed inspection and calibration data to identify trends, recommending 5+ corrective action plans that improved compliance and reduced equipment downtime by 20%.
- Collaborated in weekly cross-functional meetings with Quality, Facilities, and Operations teams to design and implement validation improvement strategies, driving a 15% increase in protocol execution efficiency.
- Documented and reported 100% of quality check findings for supervisor and regulatory review, ensuring full traceability and accountability during Health Canada and FDA inspections.
- Inspected and coordinated repair/replacement of malfunctioning equipment within 48 hours on average, minimizing workflow disruptions and maintaining >98% uptime of validated systems.
- Revised and optimized 12+ SOPs related to validation, calibration, and cleanroom practices, streamlining operations and improving team collaboration efficiency by 25%.
Quality Assurance Specialist
Intas
Ahmedabad
07.2022 - 12.2022
- Assisted in the execution of 10+ I/O/PQ protocols for cleanrooms, sterile equipment, and computer systems, ensuring compliance with GMP and Health Canada guidelines.
- Participated in validation planning and documentation updates, contributing to successful regulatory inspection with zero critical observations.
- Supported calibration scheduling and preventative maintenance tracking for 50+ critical GxP instruments, improving compliance and equipment availability.
- Partnered with senior validation engineers to perform data integrity checks and risk assessments, reinforcing compliance with FDA 21 CFR Part 11 requirements.
Quality Assurance Specialist
Toyota Boshuku
Elmira
- Conducted over 35 internal audits, enhancing compliance with ISO/TS 16949 standards by 20%.
- Analyzed inspection data from 500 production batches, improving first-pass yield by 15% within six months.
- Collaborated weekly with engineering and production teams, reducing customer complaints by 10%.
- Recorded and reported all quality check findings, ensuring accountability and audit readiness.
- Inspected and coordinated replacement of malfunctioning equipment, decreasing downtime by 12%.
- Revised more than 10 Standard Operating Procedures, boosting training efficiency for new employees by 25%.
Education
Post Secondary Diploma - Healthcare
Conestoga College Institute of Technology And Advanced Learning
Kitchener08-2024
Bachelor of Science - Pharmaceutical Sciences
Gujarat Technological University
08-2022
Skills
- Internal auditing and audits
- Quality control and assurance
- Regulatory compliance
- Data analysis and reporting
- Standard operating procedures
- Process improvement strategies
- Training and development
- Application testing and validation
- Technical documentation and writing
- Test planning and execution
Timeline
Quality Assurance Specialist
zydus pharmaceuticals
12.2022 - 02.2023
Quality Assurance Specialist
Intas
07.2022 - 12.2022
Quality Assurance Specialist
Toyota Boshuku
Post Secondary Diploma - Healthcare
Conestoga College Institute of Technology And Advanced Learning
Bachelor of Science - Pharmaceutical Sciences
Gujarat Technological University
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