RIDDHI SHAH
QC,Canada
Summary
Dedicated professional with a Master of Science in Regulatory Affairs and a Bachelor of Pharmacy, backed by comprehensive experience in quality assurance, and regulatory affairs, within the pharmaceutical and insurance sectors. Skilled in ensuring compliance with Health Canada, FDA regulations, and GMP standards. Strong communicator and team player committed to maintaining high-quality standards.
Overview
5
5
years of professional experience
1
1
Certification
Work History
QUALITY ASSURANCE ASSOCIATE
CULTURE KIZOS INC.
07.2023 - 10.2024
- Ensure completeness and accuracy of QA documentation, ensuring Good Documentation Practices on all applicable documents related to GPP
- Carrying out of CAPA, Deviations, Out of Specification (OOS) investigations
- New Cannabis Product (NCP) submissions to Health Canada
- Assistance with the creation, revision, and enforcement of our Standard Operating Procedures (SOPs), Work Instructions, and Preventative Control Plans (PCP)
- Support the team with compliance requirements, follow-up, and recommendations to ensure the quality of products is up to standards and consistent
- Resolve customer complains concerning the quality of products from the Ontario Cannabis Store
- Review, manage, and file records for all quality related activities within the facility.
- Collected and analyzed data from analytical testing, spotting patterns and anomalies to enhance the performance and quality of the product.
- Working to update the CTLS (Cannabis Tracking and Licensing System) database for the company
- Effectively coordinated mock recall simulations following Health Canada regulations, including drafting comprehensive documentation to ensure regulatory adherence and preparedness
- Provide support to the team with Health Canada and other external audits
PHARMACEUTICAL REGULATORY AFFAIRS INTERN
CROWN COLLEGE OF CANADA
04.2023 - 07.2023
- Preparation for new drug submission (NDS) for Health Canada in e-CTD format
- Assisted in the preparation and submission of regulatory documents in eCTD format for various pharmaceutical products
- Compiled and formatted documents according to regulatory guidelines
- Reviewed and edited regulatory documents for accuracy and completeness
- Participated in regulatory project management activities
- Developed regulatory strategies for new drug submissions.
SENIOR CLAIM ASSOCIATE
ICICI PRUDENTIAL LIFE INSURANCE
10.2020 - 10.2021
- Preparing submissions for the Insurance Regulatory and Development Authority, ensuring compliance with regulatory requirements
- Provided audit support and document preparation during the audits, ensuring adherence to quality standards and Good Manufacturing Standards (GMP)
- Evaluated and determined insurance coverage based on regulations, minimizing risks and ensuring compliance
- Successfully completed and implemented the project 'Claims for Sure', showcasing project management skills and delivering successful outcomes.
RESEARCH ASSOCIATE/ANALYTICAL CHEMIST
MUMBAI UNIVERSITY
11.2019 - 06.2020
- Exploratory Studies on Symmetrical Chalcones as Bioactive Agents: Electronic Effect
- Evaluated the potential anticancer properties of onion root tips by measuring their effect on the mitotic activity of cancer cells
- Infrared Spectroscopy Analysis, Preliminary biological activities, antibacterial activity, TLC method development, reaction optimization, and preclinical toxicology, such as conducting studies on bioactive agents, performing spectroscopy analysis, developing analytical methods, and optimizing reactions
- Conducted experiments to synthesize and purify various organic compounds
- Performed qualitative and quantitative analysis of synthesized compounds using various analytical techniques
- Detecting the potential anticancer properties.
QUALITY ASSURANCE AND MANUFACTURING INTERN
TWILIGHT LITAKA
06.2019 - 07.2019
- Engaging in problem-solving and root-cause analysis to address quality concerns and enhance production methods
- Conducting quality-control tests and monitoring manufacturing processes to assure regulatory compliance and Good Manufacturing Practices (GMP)
- Collaborating with cross-functional teams, including R&D, operations, and quality assurance, to support drug product development and manufacturing
- Participating in training and professional development opportunities to enhance knowledge and abilities pertaining to pharmaceutical production and quality.
Education
Master of Science in Regulatory Affairs - Regulatory Affairs And Quality Operations
Northeastern University
Toronto, Canada07.2023
Bachelor of Pharmacy - Pharmacy
Mumbai University
Mumbai, India10.2020
Skills
- Knowledge of auditing processes and regulations
- Knowledgeable of Good Manufacturing Practices (GMP) and Health Canada and FDA regulations
- Knowledge of quality management systems (QMS), such as product release, document management, change control, investigation, and corrective and preventive actions (CAPAs)
- Comprehensive knowledge of eCTD preparation process and regulatory guidelines
- Capability to work efficiently in a team and cooperate with local and international quality teams
- Excellent written and verbal English communication abilities
- Competent with Microsoft Office, Word, Excel, and PowerPoint
- Ability to draft, revise, and maintain standard policy documents, standard operating procedures
Languages
English
Full Professional
Certification
- Internal Auditor Certification for medical devices based on ISO 13485:2016 (Completed)|Certificate #: IN/22631/233248 |TUV SUD
- HACCP (Hazard Analysis Critical Control Point) For Food Safety ISO 22000
Timeline
QUALITY ASSURANCE ASSOCIATE
CULTURE KIZOS INC.
07.2023 - 10.2024
PHARMACEUTICAL REGULATORY AFFAIRS INTERN
CROWN COLLEGE OF CANADA
04.2023 - 07.2023
SENIOR CLAIM ASSOCIATE
ICICI PRUDENTIAL LIFE INSURANCE
10.2020 - 10.2021
RESEARCH ASSOCIATE/ANALYTICAL CHEMIST
MUMBAI UNIVERSITY
11.2019 - 06.2020
QUALITY ASSURANCE AND MANUFACTURING INTERN
TWILIGHT LITAKA
06.2019 - 07.2019
Master of Science in Regulatory Affairs - Regulatory Affairs And Quality Operations
Northeastern University
Bachelor of Pharmacy - Pharmacy
Mumbai University
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