Jaykumar Varma Email & Phone Number

Petrolia, On, Ca

Petrolia

• Managed documentation accuracy and completeness, supporting team adherence to regulatory standards and productquality requirements.• Contributed to the creation, review, and implementation of Standard Operating Procedures and Preventative ControlPlans.• Maintained proper filing and documentation of all quality assurance activities also, helping with the monthlypreparation of CTLS, ensuring alignment with company standards.• Assisted with CRA and other external audits, ensuring compliance with applicable regulations,including the Health Canada Cannabis Act.• Verified and released incoming materials, reviewed Certificates of Analysis (COA), and conducted sampling andsending samples to labs for testing.• Collaborated with the quality team to uphold high standards, implemented process improvements, and provided timely reports and documentation.

Bécancour, Quebec, Canada

• Implemented a streamlined process for updating SOPs and work instructions, along with a comprehensive SOP dataentry system, and maintained facility logs, resulting in a 30% improvement in document accuracy and complianceand a 20% increase in efficiency.• Managed day-to-day operations, ensuring compliance with regulatory requirements and facilitating smoothproduction processes.• Coordinated and participated in the preparation and testing of samples for third-party labs, reducing turnaround timeby 15% and improving communication with lab personnel for seamless results review.• Maintained a meticulous filing system for all Quality Management System (QMS) documentation, resulting in a 20%increase in efficiency and ease of access for regulatory audits.• Reviewed and issued status labels for manufacturing batch documents, ensuring compliance with the QMS scheduleand reducing errors by 15%.• Conducted thorough investigations into CAPA, Deviations, and OOS cases, resulting in a 20% reduction in quality-related incidents and an increase in product consistency

• Developed a comprehensive regulatory strategy for product development, registration, and launch at Crown MedicalResearch and Pharmaceutical Sciences College of Canada, resulting in a 30% increase in project efficiency based onthe Gantt chart created.• Successfully prepared NDS in eCTD format for Health Canada, leading to a 20% reduction in submission time andan expedited review process.• Implemented weekly group meetings to report and discuss project progress based on the Regulatory project Ganttchart, improving communication and alignment among team members by 40%

Toronto, Ontario, Canada

28 Tank House Lane, On M5A 3C4

Mumbai Area, India

• Led the analysis and resolution of high-profile complaints, resulting in a 15% reduction in overall complaintprocessing time.• Collaborated with the QAS Daily Review team to implement new strategies for handling records, leading to a 10%increase in efficiency.• Supported audits and inspections of the QAS group by providing detailed data on product complaints, volumes, anddeviation reports as required.• Coordinated recall or market withdrawal activities as necessary, including the management of all communicationswith regulatory agencies such as the FDA through MedWatch and MSB reports, to ensure compliance with regulatorystandards while minimising the potential financial impact on the company.• Analysed and consolidated global data for product and service quality, resulting in the implementation of new processesthat improved overall customer satisfaction by 15%.• Experience working with different software such as SAP, TrackWise, and Oracle.

Mumbai Area, India

Master'S Degree, Drug Regulatory Affairs

Bachelor Of Pharmacy - Bpharm, Bpharmacy