Jaykumar Varma
Tillsonburg,ON
Summary
Competent quality assurance specialist with several years of experience in oversight of product excellence. Proven record of quality leadership in all facets of production, team performance and fulfillment or delivery. Strategic in planning, implementing and improving processes and standards which generate opportunities for sustainable company growth.
Overview
7
7
years of professional experience
Work History
Quality Assurance Specialist
Maricann
Tillsonburg, Ontario
03.2025 - Current
- Monitored production, packaging, storage, and labeling processes for compliance with SOPs, EU-GMP and GPP standards.
- Conducted inspections and sampling of raw materials and finished products to maintain quality assurance.
- Verified incoming materials against quality standards, ensuring proper documentation before production use.
- Issued and maintained batch production records and packaging documentation for traceability.
- Investigated deviations and complaints, contributing to root cause analyses and corrective actions.
- Maintained cleaning and sanitation protocols across production areas to uphold hygiene standards.
- Supported QA Manager in employee training, regulatory compliance, and internal audits.
- Coordinated shipping orders and documentation for regulatory testing with third-party labs.
<ul><li>Managed documentation accuracy and completeness, supporting team adherence to regulatory standards and product quality requirements.</li><li>Contributed to the creation, review, and implementation of Standard Operating Procedures and Preventative Control Plans.</li><li>Maintained proper filing and documentation of all quality assurance activities, facilitating the monthly preparation of CTLS and ensuring alignment with company standards.</li><li>Assisted with Health Canada, CRA, and other external audits, guaranteeing compliance with applicable regulations, including the Health Canada Cannabis Act.</li><li>Verified and released incoming raw materials, reviewed Certificates of Analysis (COA), and conducted sampling, sending samples to labs for testing.</li><li>Collaborated with the quality team to uphold high standards, orchestrated process improvements, and provided timely reports and documentation.</li></ul>
Cannim Canada Ltd.
Petrolia
09.2024 - Current
- Managed documentation accuracy and completeness, supporting team adherence to regulatory standards and product quality requirements.
- Contributed to the creation, review, and implementation of Standard Operating Procedures and Preventative Control Plans.
- Maintained proper filing and documentation of all quality assurance activities, facilitating the monthly preparation of CTLS and ensuring alignment with company standards.
- Assisted with Health Canada, CRA, and other external audits, guaranteeing compliance with applicable regulations, including the Health Canada Cannabis Act.
- Verified and released incoming raw materials, reviewed Certificates of Analysis (COA), and conducted sampling, sending samples to labs for testing.
- Collaborated with the quality team to uphold high standards, orchestrated process improvements, and provided timely reports and documentation.
<ul><li>Developed and implemented a comprehensive regulatory compliance programme for a medical device manufacturer, ensuring adherence to MDSAP, EU MDR, and ISO 13485:2016 standards, resulting in a successful audit with zero major findings.</li><li>Spearheaded internal audits on technical documentation for new product development projects, identifying and resolving compliance issues related to Health Canada, 21 CFR 820, and 510(k) submissions, driving a 20% decrease in regulatory submission errors.</li><li>Collaborated with cross-functional teams to streamline the DHF, DMR, and DHR processes for active devices, enhancing time-to-market for new product innovations by 15%.</li></ul>
Check It Done Services Ltd.
Vancouver
12.2023 - 09.2024
- Developed and implemented a comprehensive regulatory compliance programme for a medical device manufacturer, ensuring adherence to MDSAP, EU MDR, and ISO 13485:2016 standards, resulting in a successful audit with zero major findings.
- Spearheaded internal audits on technical documentation for new product development projects, identifying and resolving compliance issues related to Health Canada, 21 CFR 820, and 510(k) submissions, driving a 20% decrease in regulatory submission errors.
- Collaborated with cross-functional teams to streamline the DHF, DMR, and DHR processes for active devices, enhancing time-to-market for new product innovations by 15%.
<ul><li>Implemented a streamlined process for updating SOPs and work instructions along with a comprehensive SOP data entry system, maintaining facility logs and achieving a 30% improvement in document accuracy and compliance and a 20% boost in efficiency.</li><li>Managed day-to-day operations, ensuring compliance with regulatory requirements and facilitating smooth production processes.</li><li>Coordinated and participated in the preparation and testing of samples for third-party labs, resulting in a 15% reduction in turnaround time and enhancing communication with lab personnel for seamless results review.</li><li>Maintained a meticulous filing system for all Quality Management System (QMS) documentation, increasing efficiency by 20% and improving access for regulatory audits.</li><li>Reviewed and issued status labels for manufacturing batch documents, ensuring compliance with the QMS schedule and decreasing errors by 15%.</li><li>Conducted thorough investigations into CAPA, Deviations, and OOS cases, achieving a 20% reduction in quality-related incidents and enhancing product consistency.</li></ul>
Culture Kizos
Becancour
07.2023 - 09.2024
- Implemented a streamlined process for updating SOPs and work instructions along with a comprehensive SOP data entry system, maintaining facility logs and achieving a 30% improvement in document accuracy and compliance and a 20% boost in efficiency.
- Managed day-to-day operations, ensuring compliance with regulatory requirements and facilitating smooth production processes.
- Coordinated and participated in the preparation and testing of samples for third-party labs, resulting in a 15% reduction in turnaround time and enhancing communication with lab personnel for seamless results review.
- Maintained a meticulous filing system for all Quality Management System (QMS) documentation, increasing efficiency by 20% and improving access for regulatory audits.
- Reviewed and issued status labels for manufacturing batch documents, ensuring compliance with the QMS schedule and decreasing errors by 15%.
- Conducted thorough investigations into CAPA, Deviations, and OOS cases, achieving a 20% reduction in quality-related incidents and enhancing product consistency.
<ul><li>Conducted rigorous testing on products to ensure adherence to GMPs, contributing to a 20% reduction in defects.</li><li>Performed thorough audits on all manufacturing equipment and processes, identifying areas for improvement and increasing efficiency by 15%.</li><li>Assisted in the formulation of new SOPs and GMPs that reduced product defects by 20%, leading to higher customer satisfaction rates.</li></ul>
Shah Trading Company
Scarborough
04.2022 - 09.2022
- Conducted rigorous testing on products to ensure adherence to GMPs, contributing to a 20% reduction in defects.
- Performed thorough audits on all manufacturing equipment and processes, identifying areas for improvement and increasing efficiency by 15%.
- Assisted in the formulation of new SOPs and GMPs that reduced product defects by 20%, leading to higher customer satisfaction rates.
<ul><li>Led the analysis and resolution of high-profile complaints, resulting in a 15% reduction in overall complaint processing time.</li><li>Collaborated with the QAS Daily Review team to implement innovative strategies for handling records, coordinating with the pharmacovigilance team to report adverse events to regulatory authorities and resolving issues received from the FDA through MedWatch reports.</li><li>Supported audits and inspections of the QAS group by providing comprehensive data on product complaints, volumes, and deviation reports as required.</li><li>Coordinated recall or market withdrawal activities as necessary, including the management of all communications with regulatory agencies such as the FDA through MedWatch and MSB reports.</li><li>Analyzed and consolidated global data for product and service quality, implementing new processes that improved overall customer satisfaction by 15%.</li></ul>
Teva Pharmaceuticals
Mumbai
05.2019 - 02.2021
- Led the analysis and resolution of high-profile complaints, resulting in a 15% reduction in overall complaint processing time.
- Collaborated with the QAS Daily Review team to implement innovative strategies for handling records, coordinating with the pharmacovigilance team to report adverse events to regulatory authorities and resolving issues received from the FDA through MedWatch reports.
- Supported audits and inspections of the QAS group by providing comprehensive data on product complaints, volumes, and deviation reports as required.
- Coordinated recall or market withdrawal activities as necessary, including the management of all communications with regulatory agencies such as the FDA through MedWatch and MSB reports.
- Analyzed and consolidated global data for product and service quality, implementing new processes that improved overall customer satisfaction by 15%.
<ul><li>Conducted customer visits to gather requirements and demonstrate offerings, resulting in an increased customer base of 30%.</li><li>Prospected continuously for new customers using market segmentation, which led to a 15% increase in market share and revenue growth.</li><li>Implemented an effective prospecting strategy, resulting in the acquisition of 30 new customers within the first quarter while maintaining a 90% sales conversion rate.</li><li>Executed thorough analysis of product quality data to identify trends and potential areas for improvement, achieving a 15% increase in customer satisfaction ratings.</li></ul>
Medi TransCare Pvt. Ltd
Mumbai
08.2018 - 04.2019
- Conducted customer visits to gather requirements and demonstrate offerings, resulting in an increased customer base of 30%.
- Prospected continuously for new customers using market segmentation, which led to a 15% increase in market share and revenue growth.
- Implemented an effective prospecting strategy, resulting in the acquisition of 30 new customers within the first quarter while maintaining a 90% sales conversion rate.
- Executed thorough analysis of product quality data to identify trends and potential areas for improvement, achieving a 15% increase in customer satisfaction ratings.
Education
Masters - Drug Regulatory Affairs
Toronto, Canada
Toronto, Canada07.2023
Bachelor’s - Pharmacy
Mumbai, India
Mumbai, India05.2018
Skills
- Documentation and reporting
- Product recall management
- Attention to detail
- Problem solving
- Compliance auditing
- Quality management
- Root cause analysis
- Standard operating procedures
- Risk assessment
- Sampling
- Internal audits
Languages
English, Hindi
References
References available upon request.
Timeline
Quality Assurance Specialist
Maricann
03.2025 - Current
<ul><li>Managed documentation accuracy and completeness, supporting team adherence to regulatory standards and product quality requirements.</li><li>Contributed to the creation, review, and implementation of Standard Operating Procedures and Preventative Control Plans.</li><li>Maintained proper filing and documentation of all quality assurance activities, facilitating the monthly preparation of CTLS and ensuring alignment with company standards.</li><li>Assisted with Health Canada, CRA, and other external audits, guaranteeing compliance with applicable regulations, including the Health Canada Cannabis Act.</li><li>Verified and released incoming raw materials, reviewed Certificates of Analysis (COA), and conducted sampling, sending samples to labs for testing.</li><li>Collaborated with the quality team to uphold high standards, orchestrated process improvements, and provided timely reports and documentation.</li></ul>
Cannim Canada Ltd.
09.2024 - Current
<ul><li>Developed and implemented a comprehensive regulatory compliance programme for a medical device manufacturer, ensuring adherence to MDSAP, EU MDR, and ISO 13485:2016 standards, resulting in a successful audit with zero major findings.</li><li>Spearheaded internal audits on technical documentation for new product development projects, identifying and resolving compliance issues related to Health Canada, 21 CFR 820, and 510(k) submissions, driving a 20% decrease in regulatory submission errors.</li><li>Collaborated with cross-functional teams to streamline the DHF, DMR, and DHR processes for active devices, enhancing time-to-market for new product innovations by 15%.</li></ul>
Check It Done Services Ltd.
12.2023 - 09.2024
<ul><li>Implemented a streamlined process for updating SOPs and work instructions along with a comprehensive SOP data entry system, maintaining facility logs and achieving a 30% improvement in document accuracy and compliance and a 20% boost in efficiency.</li><li>Managed day-to-day operations, ensuring compliance with regulatory requirements and facilitating smooth production processes.</li><li>Coordinated and participated in the preparation and testing of samples for third-party labs, resulting in a 15% reduction in turnaround time and enhancing communication with lab personnel for seamless results review.</li><li>Maintained a meticulous filing system for all Quality Management System (QMS) documentation, increasing efficiency by 20% and improving access for regulatory audits.</li><li>Reviewed and issued status labels for manufacturing batch documents, ensuring compliance with the QMS schedule and decreasing errors by 15%.</li><li>Conducted thorough investigations into CAPA, Deviations, and OOS cases, achieving a 20% reduction in quality-related incidents and enhancing product consistency.</li></ul>
Culture Kizos
07.2023 - 09.2024
<ul><li>Conducted rigorous testing on products to ensure adherence to GMPs, contributing to a 20% reduction in defects.</li><li>Performed thorough audits on all manufacturing equipment and processes, identifying areas for improvement and increasing efficiency by 15%.</li><li>Assisted in the formulation of new SOPs and GMPs that reduced product defects by 20%, leading to higher customer satisfaction rates.</li></ul>
Shah Trading Company
04.2022 - 09.2022
<ul><li>Led the analysis and resolution of high-profile complaints, resulting in a 15% reduction in overall complaint processing time.</li><li>Collaborated with the QAS Daily Review team to implement innovative strategies for handling records, coordinating with the pharmacovigilance team to report adverse events to regulatory authorities and resolving issues received from the FDA through MedWatch reports.</li><li>Supported audits and inspections of the QAS group by providing comprehensive data on product complaints, volumes, and deviation reports as required.</li><li>Coordinated recall or market withdrawal activities as necessary, including the management of all communications with regulatory agencies such as the FDA through MedWatch and MSB reports.</li><li>Analyzed and consolidated global data for product and service quality, implementing new processes that improved overall customer satisfaction by 15%.</li></ul>
Teva Pharmaceuticals
05.2019 - 02.2021
<ul><li>Conducted customer visits to gather requirements and demonstrate offerings, resulting in an increased customer base of 30%.</li><li>Prospected continuously for new customers using market segmentation, which led to a 15% increase in market share and revenue growth.</li><li>Implemented an effective prospecting strategy, resulting in the acquisition of 30 new customers within the first quarter while maintaining a 90% sales conversion rate.</li><li>Executed thorough analysis of product quality data to identify trends and potential areas for improvement, achieving a 15% increase in customer satisfaction ratings.</li></ul>
Medi TransCare Pvt. Ltd
08.2018 - 04.2019
Masters - Drug Regulatory Affairs
Toronto, Canada
Bachelor’s - Pharmacy
Mumbai, India