PURVI RASHMIKANT RAVAL
Windsor,ON
Summary
Quality Assurance professional with over 8 years of experience in pharmaceutical and nutraceutical sectors. Expertise in GMP, HACCP, and regulatory compliance, ensuring audit readiness and quality system integrity. Demonstrated ability to lead cross-functional teams, enhance documentation processes, and implement continuous improvement initiatives aligned with Health Canada and FDA standards. Proven success in supporting product launches while maintaining robust quality frameworks.
Overview
13
13
years of professional experience
1
1
Certification
Work History
<ul><li>Led documentation control across all nutraceutical product lines, ensuring audit-ready compliance with Canadian and U.S. regulations.</li><li>Developed and optimized master documents, SOPs, batch records, and CoAs, improving operational efficiency and regulatory alignment.</li><li>Partnered with QA, Regulatory, and Supply Chain teams to support new product launches and successful Health Canada/FDA inspections.</li><li>Managed documentation workflows with strict adherence to timelines.</li></ul>
Nutriza Inc.
Toronto, ON
03.2023 - Current
- Led documentation control across all nutraceutical product lines, ensuring audit-ready compliance with Canadian and U.S. regulations.
- Developed and optimized master documents, SOPs, batch records, and CoAs, improving operational efficiency and regulatory alignment.
- Partnered with QA, Regulatory, and Supply Chain teams to support new product launches and successful Health Canada/FDA inspections.
- Managed documentation workflows with strict adherence to timelines.
ul liEnsured facility-wide compliance with GMP, Health Canada, NSF, and FDA requirements in all manufacturing and packaging operations./li liReviewed and approved Batch Manufacturing Records (BMRs) and Packaging Records, ensuring accuracy, completeness, and GMP alignment./li liInvestigated deviations, customer complaints, and OOS results, initiating and tracking CAPAs through resolution and effectiveness checks./li liLed internal GMP audits and prepared the facility for NSF and Health Canada inspections, resulting in positive audit outcomes./li liCoordinated product release and quarantine, reviewing quality documentation to ensure conformance before final disposition./li liParticipated in change control evaluations for new equipment, materials, or process modifications./li liReviewed and approved labels, packaging materials, and marketing claims in alignment with NHPD and FDA guidelines./li liDelivered GMP and SOP training sessions for QA, QC, and production staff; maintained accurate training records./li liSupported stability study reviews and shelf-life verification of nutraceutical products./li liPrepared and submitted quality performance reports (e.g., deviation trends, audit status, CAPA tracking) to management./li/ul
Medicap Laboratories
Windsor, ON
05.2018 - 03.2023
- Ensured facility-wide compliance with GMP, Health Canada, NSF, and FDA requirements in all manufacturing and packaging operations.
- Reviewed and approved Batch Manufacturing Records (BMRs) and Packaging Records, ensuring accuracy, completeness, and GMP alignment.
- Investigated deviations, customer complaints, and OOS results, initiating and tracking CAPAs through resolution and effectiveness checks.
- Led internal GMP audits and prepared the facility for NSF and Health Canada inspections, resulting in positive audit outcomes.
- Coordinated product release and quarantine, reviewing quality documentation to ensure conformance before final disposition.
- Participated in change control evaluations for new equipment, materials, or process modifications.
- Reviewed and approved labels, packaging materials, and marketing claims in alignment with NHPD and FDA guidelines.
- Delivered GMP and SOP training sessions for QA, QC, and production staff; maintained accurate training records.
- Supported stability study reviews and shelf-life verification of nutraceutical products.
- Prepared and submitted quality performance reports (e.g., deviation trends, audit status, CAPA tracking) to management.
<ul><li>Coordinated QC testing activities for raw materials, in-process samples, and finished products as per pharmacopeial and internal specifications.</li><li>Scheduled and prioritized analytical work in coordination with production timelines and batch release requirements.</li><li>Ensured proper sampling procedures and documentation in accordance with GMP and regulatory standards.</li><li>Reviewed and approved COAs (Certificates of Analysis), analytical reports, and data entries in manual systems.</li><li>Managed instrument calibration schedules, maintenance logs, and ensured compliance with GLP standards.</li><li>Supported method development and validation activities for new product testing in coordination with the R&D and QA teams.</li><li>Handled OOS (Out-of-Specification) results by initiating investigations and coordinating with QA for CAPA implementation.</li><li>Prepared for and supported regulatory and customer audits, ensuring timely availability of test data and records.</li></ul>
Medicap Laboratories
Windsor, ON
05.2015 - 05.2018
- Coordinated QC testing activities for raw materials, in-process samples, and finished products as per pharmacopeial and internal specifications.
- Scheduled and prioritized analytical work in coordination with production timelines and batch release requirements.
- Ensured proper sampling procedures and documentation in accordance with GMP and regulatory standards.
- Reviewed and approved COAs (Certificates of Analysis), analytical reports, and data entries in manual systems.
- Managed instrument calibration schedules, maintenance logs, and ensured compliance with GLP standards.
- Supported method development and validation activities for new product testing in coordination with the R&D and QA teams.
- Handled OOS (Out-of-Specification) results by initiating investigations and coordinating with QA for CAPA implementation.
- Prepared for and supported regulatory and customer audits, ensuring timely availability of test data and records.
<ul><li>Assisted in performing quality control checks on clinical diagnostic instruments, reagents, and test results to ensure accuracy and reliability.</li><li>Verified calibration and maintenance logs for laboratory equipment such as biochemistry analyzers, hematology counters, and microscopes.</li><li>Monitored and documented daily QC runs for internal and external quality assurance programs.</li><li>Helped maintain reagent inventory, ensured proper storage conditions, and tracked expiration dates.</li><li>Prepared and labeled QC samples, ensuring traceability and correct documentation as per lab protocols.</li><li>Assisted in investigating QC failures or discrepancies, escalating issues to senior lab technologists or supervisors.</li><li>Supported compliance with laboratory Standard Operating Procedures (SOPs) and participated in routine internal audits.</li><li>Ensured proper sample handling and identification, minimizing pre-analytical errors.</li><li>Ensured cleanliness and compliance in QC workspaces following biohazard safety protocols.</li></ul>
Vidhi Pathology Laboratory
Ahmedabad
08.2012 - 09.2014
- Assisted in performing quality control checks on clinical diagnostic instruments, reagents, and test results to ensure accuracy and reliability.
- Verified calibration and maintenance logs for laboratory equipment such as biochemistry analyzers, hematology counters, and microscopes.
- Monitored and documented daily QC runs for internal and external quality assurance programs.
- Helped maintain reagent inventory, ensured proper storage conditions, and tracked expiration dates.
- Prepared and labeled QC samples, ensuring traceability and correct documentation as per lab protocols.
- Assisted in investigating QC failures or discrepancies, escalating issues to senior lab technologists or supervisors.
- Supported compliance with laboratory Standard Operating Procedures (SOPs) and participated in routine internal audits.
- Ensured proper sample handling and identification, minimizing pre-analytical errors.
- Ensured cleanliness and compliance in QC workspaces following biohazard safety protocols.
Education
Diploma - Quality Assurance and Regulatory Affairs (QARA)
true
Mississauga, ON, Canada12-2025
Diploma - Medical Laboratory Technician
Ahmedabad, India
Ahmedabad, IndiaBachelor of Science - Microbiology
Ahmedabad, India
Ahmedabad, IndiaSkills
- Internal audits
- Corrective actions
- Preventive actions
- System inspection
- Internal audits
- Corrective actions
- Preventive actions
- System inspection
Certification
- Good Manufacturing Practices (GMP)
- HACCP Food & Pharmaceutical Safety Systems
- PRA 101 Introduction to Regulatory Affairs
References
References available upon request.
Timeline
<ul><li>Led documentation control across all nutraceutical product lines, ensuring audit-ready compliance with Canadian and U.S. regulations.</li><li>Developed and optimized master documents, SOPs, batch records, and CoAs, improving operational efficiency and regulatory alignment.</li><li>Partnered with QA, Regulatory, and Supply Chain teams to support new product launches and successful Health Canada/FDA inspections.</li><li>Managed documentation workflows with strict adherence to timelines.</li></ul>
Nutriza Inc.
03.2023 - Current
ul liEnsured facility-wide compliance with GMP, Health Canada, NSF, and FDA requirements in all manufacturing and packaging operations./li liReviewed and approved Batch Manufacturing Records (BMRs) and Packaging Records, ensuring accuracy, completeness, and GMP alignment./li liInvestigated deviations, customer complaints, and OOS results, initiating and tracking CAPAs through resolution and effectiveness checks./li liLed internal GMP audits and prepared the facility for NSF and Health Canada inspections, resulting in positive audit outcomes./li liCoordinated product release and quarantine, reviewing quality documentation to ensure conformance before final disposition./li liParticipated in change control evaluations for new equipment, materials, or process modifications./li liReviewed and approved labels, packaging materials, and marketing claims in alignment with NHPD and FDA guidelines./li liDelivered GMP and SOP training sessions for QA, QC, and production staff; maintained accurate training records./li liSupported stability study reviews and shelf-life verification of nutraceutical products./li liPrepared and submitted quality performance reports (e.g., deviation trends, audit status, CAPA tracking) to management./li/ul
Medicap Laboratories
05.2018 - 03.2023
<ul><li>Coordinated QC testing activities for raw materials, in-process samples, and finished products as per pharmacopeial and internal specifications.</li><li>Scheduled and prioritized analytical work in coordination with production timelines and batch release requirements.</li><li>Ensured proper sampling procedures and documentation in accordance with GMP and regulatory standards.</li><li>Reviewed and approved COAs (Certificates of Analysis), analytical reports, and data entries in manual systems.</li><li>Managed instrument calibration schedules, maintenance logs, and ensured compliance with GLP standards.</li><li>Supported method development and validation activities for new product testing in coordination with the R&D and QA teams.</li><li>Handled OOS (Out-of-Specification) results by initiating investigations and coordinating with QA for CAPA implementation.</li><li>Prepared for and supported regulatory and customer audits, ensuring timely availability of test data and records.</li></ul>
Medicap Laboratories
05.2015 - 05.2018
<ul><li>Assisted in performing quality control checks on clinical diagnostic instruments, reagents, and test results to ensure accuracy and reliability.</li><li>Verified calibration and maintenance logs for laboratory equipment such as biochemistry analyzers, hematology counters, and microscopes.</li><li>Monitored and documented daily QC runs for internal and external quality assurance programs.</li><li>Helped maintain reagent inventory, ensured proper storage conditions, and tracked expiration dates.</li><li>Prepared and labeled QC samples, ensuring traceability and correct documentation as per lab protocols.</li><li>Assisted in investigating QC failures or discrepancies, escalating issues to senior lab technologists or supervisors.</li><li>Supported compliance with laboratory Standard Operating Procedures (SOPs) and participated in routine internal audits.</li><li>Ensured proper sample handling and identification, minimizing pre-analytical errors.</li><li>Ensured cleanliness and compliance in QC workspaces following biohazard safety protocols.</li></ul>
Vidhi Pathology Laboratory
08.2012 - 09.2014
Diploma - Quality Assurance and Regulatory Affairs (QARA)
true
Diploma - Medical Laboratory Technician
Ahmedabad, India
Bachelor of Science - Microbiology
Ahmedabad, India