NANDINI PAREKH
Newmarket,Canada
Summary
Detail-oriented Quality Assurance professional with 4 years of experience in the pharmaceutical manufacturing industry, specializing in batch release and regulatory adherence. Skilled in supporting quality systems management, revising QMS documentation, analysis, and contributing to continuous improvement. Experienced in audits, investigations, and maintaining documentation in line with Health Canada standards. An adaptable strong communicator and team player focused on upholding the highest quality and compliance standards.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Quality Assurance Technician
Rubicon Organics
01.2021 - Current
- Managed, reviewed, and retained operational documentation leading to Bulk batch releases for local market products, including new launches, ensuring compliance with industry rules and regulations.
- Approved labels for daily operations, conducted internal site audits and inspections aligning with Health Canada's regulatory standards, reported any issues, and assisted with Quality improvement projects and the company's Quality Management System (QMS).
- Reviewed Deviations, Corrective Action, and Preventive Action (CAPA) procedures, held trend analysis addressing customer complaints, identified root causes and proposed corrective measures.
- Created Work Instructions and changed SOP following industry standards and practices with documentation following GPP, GDP and GMP guidelines, HACCP, and Critical Control Points.
- Improved documentation methods for third-party shipments, reducing review time by 25% and consistently meeting individual and team productivity goals.
- Reconciled database with internal and external clients meeting their needs, and ensuring completeness and accuracy of reports.
- Performed quality checks on reports, records, and products, and maintained data entry in the quality management system (ERP, Elevated signals).
- Played a key role in assessing, approving, and receiving raw materials and equipment with documentation for project requirements to meet quality and compliance regulations and standards.
- Supported product recalls and Return-to-Vendor (RTV) processes by analyzing associated issues and contributing to internal reporting for quality improvement.
Production Lead
Rubicon Organics
01.2020 - 01.2021
- Maintained accurate inventory records, placing orders for raw materials and supplies as needed to avoid stock shortages or delays in production schedules.
- Collaborated with Quality Control teams to address any issues identified during inspections, implementing corrective actions and reconciling inventory discrepancies and records quarterly or when needed.
- Made sure that all production staff was aware of and followed all safety standards and SOPs and reported supervisor about the production line updates.
- Approved records and product labels for on-the-line production while focusing on continued improvements on the production lines and assisting the Excellence team in implementing changes on the line.
- Introduced batch tracking system while maintaining data integrity of batch records for quality ensuring traceability and accuracy.
- Improved production efficiency in product quality by 15% through training staff and streamlining processes by introducing pre-line checks, in addition to implementing effective scheduling techniques with the supervisor.
- Led staff training and development, enhancing team proficiency and assuming senior responsibilities in management's absence to support decision-making and seamless operations.
Customer Service Representative
Leon's Furniture
01.2019 - 01.2020
- Accurately and efficiently processed purchases, returns, exchanges, and other transactions using the store's Point of Sale (POS) system.
- Maintained detailed records of client purchases and bills within the customer information system (GERS), ensuring data accuracy and accessibility.
- Addressed and assisted with approximately 30 customer queries per day in person, via mail, and over the phone, while scheduling appointments for orders and deliveries, ensuring customer satisfaction.
- Adhered to company policies and procedures regarding customer service, sales, safety, and security, ensuring compliance and maintaining the store's reputation.
- Reviewed, sorted and filled in information and documentation.
Education
Diploma in Health and Fitness - biomechanics, nutrition, muscle conditioning
Georgian College of Applied Arts and Technology
Barrie, ON04.2020
Skills
- Analytical and Problem-Solving
- ALCOA Principles
- Leadership and Time management
- Detail-Oriented
- Auditing and Inspection
- Teamwork and cross-departmental collaboration
- Flexible
Certification
- ISO 22716 (GMP)
- Quality Management Foundation
- Clinical Trials: Good Clinical Practice Specialization
- Quality in Pharmaceutical Industry: GMP & Process Validation
Projects
- Created, and revised records to compile and analyze inventory, quality, and production data, ensuring accuracy and alignment with operational standards.
- Reduced time for completing crucial external party documentation by 25% by improving documentation.
- Implemented a label version tracking system using Excel and the company’s QMS (Elevated Signals), enhancing accuracy and traceability.
Timeline
Quality Assurance Technician
Rubicon Organics
01.2021 - Current
Production Lead
Rubicon Organics
01.2020 - 01.2021
Customer Service Representative
Leon's Furniture
01.2019 - 01.2020
- ISO 22716 (GMP)
- Quality Management Foundation
- Clinical Trials: Good Clinical Practice Specialization
- Quality in Pharmaceutical Industry: GMP & Process Validation
Diploma in Health and Fitness - biomechanics, nutrition, muscle conditioning
Georgian College of Applied Arts and Technology
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