Ronik Ratneshwar
North York,Toronto
Summary
An efficiency driven Quality Assurance personnel with a 2 years of experience in the biotechnology and regenerative medicine industry and 3+ years of experience in the food industry. Collaborative with cross-functional groups and can work independently with minimal supervision. Educational background in Genetics and Food Science with a keen interest in regenerative medicine. Strong believer and follower of interpersonal skills and stress management.
Overview
8
8
years of professional experience
Work History
Quality Assurance Associate I
Centre for Commercialization of Regenerative Medicine (CCRM)
Toronto, ON
05.2022 - Current
- Leading Key Performance Indicators (KPIs) monitoring by maintaining and trending departmental KPI data, preparing and presenting weekly and monthly QA KPI dashboards, following up with the cross-departmental stakeholders to ensure timely and effective closure of overdue action items.
- Leading material release team to facilitate release of incoming materials in a compliant manner by reviewing vendor Certificate of Analysis (COAs) against internal Material Specification Sheets.
- Reviewing equipment validation documents including but not limited to, vendor and internal Installation, Operational, and Performance Qualification (IOPQ) documents, Impact Assessments, Criticality Assessments, etc.
- Reviewing master and executed batch records for IPSCs reprogramming, MCBs, and WCBs; conducting batch closure QA activities such as batch record signoffs and retention, overseeing vial retrieval, issuing batch COAs, etc.
- Collaborating with cross-functional teams to assist in the development and implementation of SOPs, master equipment validation documents, new EQMS systems, completing audit action items, cross-functional trainings, etc.
- Supporting and serving as a backup for compliance associate by carrying out document issuance, training coordination, supplier assessments, job codes assignment, etc.
- Reviewing and assessing equipment and client tech transfer change controls, facility issue reviews, incident reports and CAPAs.
- Assigning change controls and Issue Reviews to applicable Quality personnel to ensure timely action.
Quality Assurance Coordinator
Just Quality International Inc.
Toronto, ON
10.2020 - 05.2022
- Reviewing and managing supplier documentation.
- Completing supplier verifications in a timely manner.
- Conducting internal audits against BRCGS Agents & Brokers.
- Developing and maintaining product specifications and SOPs.
- Developing Nutritional Panels for products and reviewing label artworks.
- Probing and responding to customer complaints and preparing statistical charts to analyze complaint trends.
- Reviewing and responding to customer requests for documents.
Quality Assurance Technician
Vaughn Mills Packaging Ltd
Concord, ON
04.2019 - 07.2020
- Conducting Pre-Operational and Operational Inspection within the plant.
- Conducting sensory evaluations on all the finished products and releasing them.
- Maintaining the allergen segregation program, glass and rigid plastic program, and sampling the finished products.
- Maintaining the sanitation program by carrying out visual, ATP swab method and finished product analysis.
- Maintaining and verifying all the documentation for daily production of the products.
- Produced thorough reports detailing findings and proposed recommendations.
- Completed routine inspections of components and products to fulfill quality assurance requirements.
- Recruited, trained and scheduled employees to fulfill quality standards and expectations of management.
- Developed Quality Audits to identify and track defects in products prior to mass production.
- Randomly selected products at various stages of production for evaluation.
- Analyzed issues and recommended corrective actions to improve final results.
Quality Control Technician
Trupti Enterprises
East York, ON
- 01.2019
- Maintaining the allergen program in the facility.
- Developing SOP’s for manufacturing, sanitation and maintaining processes.
- Developing product specification sheet for different products and communicating with the suppliers regarding the same.
- Ensuring that lot numbers are accurately placed and sanitation program is in function.
- Conducting Good Manufacturing Practices walk through daily to ensure that the facility is following them.
- Communicating with sample testing labs and conducting microbial tests on equipment and food contact surfaces.
Vice President
The Wishing Factory (NGO)
Vadodara , India
01.2016 - 01.2017
- Managing and helping in the fulfillment of wishes of the thalassemia patients and lead the team to manage the events during the organization’s events.
- Conducting volunteer and executive team meetings and publishing the monthly reports for the organization.
- Communicating with the wish sponsors and patients for effective organization of the wish fulfillment process.
Education
Food Science Technology - Fast Track Program -
Centennial College
04.2018
Bachelors in Science - Genetics
Sardar Patel University
06.2016
Skills
- Familiar with techniques and steps involved in the assessment of change controls, issue reviews, incident reports and Corrective and Preventive Actions (CAPAs)
- Efficient with the review of quality documentation such as Master and Executed Batch Record reviews; Equipment validation documents (IOQ documents, Criticality Assessments); cleanroom logbooks; Standard Operating Procedures
- High expertise with the knowledge of Good Manufacturing Practices (GMPs); Good Laboratory Practices (GLPs); and Good Documentation Practices (GDPs)
- Key Performance Indicators (KPIs) monitoring
- High working efficiency and familiarity with EQMS vendors such as MasterControl, SAP and POMSnet
- High working efficiency and familiarity with the MS Office suite (Word, Excel, PowerPoint, and Outlook)
Timeline
Quality Assurance Associate I
Centre for Commercialization of Regenerative Medicine (CCRM)
05.2022 - Current
Quality Assurance Coordinator
Just Quality International Inc.
10.2020 - 05.2022
Quality Assurance Technician
Vaughn Mills Packaging Ltd
04.2019 - 07.2020
Vice President
The Wishing Factory (NGO)
01.2016 - 01.2017
Quality Control Technician
Trupti Enterprises
- 01.2019
Food Science Technology - Fast Track Program -
Centennial College
Bachelors in Science - Genetics
Sardar Patel University
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