NANDINI PAREKH
Summary
Quality Assurance Technician looking to transition into a Regulatory Affairs Associate role, with 4 years of experience in the pharmaceutical industry. Skilled in regulatory documentation management, compliance tracking, and submission support for Health Canada. Expertise in uploading, tracking, and maintaining regulatory files, coordinating regulatory samples, and ensuring inspection readiness. Strong knowledge of GMP, GDP, and regulatory requirements, with a proven ability to streamline documentation processes and support audits. Adept at collaborating with cross-functional teams to enhance regulatory compliance and process improvements.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Quality Assurance Technician
Rubicon Organics
02.2021 - Current
- Managed regulatory documentation, including uploading, tracking, and maintaining product-specific files in compliance with regulatory guidelines and quality standards.
- Assisted in the preparation, submission, and tracking of regulatory applications, ensuring alignment with Health Canada requirements
- Coordinated regulatory samples submission, sample tracking, and legal documentation, including Certificates of Analysis.
- Provided and executed process improvement to enhance efficiency in submissions and document management.
- Supported Regulatory & Quality team by managing QMS like ERP and Elevated Signals, conducting checks to ensure inspection readiness.
- Acted as a designated point of contact for internal documentation systems, providing support and guidance to cross-functional teams on compliance and regulatory documentation management.
- Supported audits and inspections by ensuring all regulatory files were maintained and readily accessible for review.
- Assessed and approved raw materials and equipment, ensuring supplier compliance and regulatory alignment.
Processing Lead
Rubicon Organics
01.2020 - 01.2021
- Maintained accurate inventory and batch records, ensuring quality and safety standards compliance.
- Worked closely with Quality Control teams to resolve compliance issues.
- Supervised line operations, ensuring adherence to safety standards and SOPs, and implemented pre-line checks to streamline processes.
- Introduced batch tracking system maintaining data integrity of batch records for quality, ensuring traceability and accuracy.
- Led cross-functional training sessions to enhance team proficiency.
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
Education
Diploma - Health And Fitness
Georgian College of Applied Arts and Technology
Barrie, Ontario04.2020
Skills
- Equipment and Material management
- Tracking & Data Management
- Vendor & Supplier Documentation Review
- Audit Preparation & Quality Control
- Microsoft Excel & Office Proficiency
- Problem-Solving & Process Improvement
- Regulatory Compliance & Documentation Management
Certification
- SGS Certified ISO 22716 (GMP)
- Clinical Trials: Good Clinical Practice Specialization (Novartis Certified)
- Quality in Pharmaceutical Industry: GMP & Process Validation
- Quality Management Foundation
Accomplishments
- Supported regulatory compliance efforts by maintaining accurate documentation and tracking regulatory materials.
- Assisted with regulatory submissions for FVOPA certification, ensuring compliance with organic product standards and reducing documentation review time for third-party shipments.
- Developed tracking systems for quality and compliance data, ensuring audit readiness.
- Generated analytical reports for audits, deviations, and CAPA processes to support compliance and continuous improvement.
- Demonstrated adaptability in learning new digital tools, including systems for documentation and training management.
Timeline
Quality Assurance Technician
Rubicon Organics
02.2021 - Current
Processing Lead
Rubicon Organics
01.2020 - 01.2021
Customer Service Representative
Leon's Furniture
01.2019 - 01.2020
Diploma - Health And Fitness
Georgian College of Applied Arts and Technology
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