Quality Assurance Specialist
7 months ago
**The Quality Assurance Specialist is mainly responsible for overseeing the importation of Natural Health Products, preparation of Product Master Files/Quality Summary Reports and NNHPD FPS as well as incorporating new products into the Quality Management System.**
**Responsibilities**:
- Continuous review of imported product samples and labels.
- Review of documentation for the release of imported products including C of A, C of Ms, Receiving Records, Batch Records, OOS/laboratory test reports.
- Liaise with clients to request product release documentation, communicate discrepancies, provide updates, and respond to questions to ensure a smooth/timely product release process.
- Prepare product review and release reports and label review reports.
- Develop, recommend and monitor corrective actions when issues with the imported products arise.
- Review and approve product destruction and return reports.
- Determine testing requirements and justifications for testing.
- Prepare NNHPD FPS submission documents based on approved QSRs.
- Review of label artworks.
- Prepare Quality Summary Reports and revise Standard Operating Procedures.
- Identify areas of improvement and address/implement changes to improve processes and documentation.
- Management of assigned accounts.
- Review, manage and respond to ePost communications. Handling all epost communications with the NNHPD on behalf of dicentra.
- Liaises between clients and government agencies in both Canada and the USA to ensure all stakeholders have accurate information and a clear understanding of quality and regulatory requirements related to importation and GMP.
- Complete the Quality Section of Product Licence Applications (NHPs) and GRAS dossiers.
- Other ad hoc tasks within the department based on experience and availability to assist.
- Preparing International Trade Certificates.
**Job Qualifications**:
- Bachelor’s degree in the health sciences or similar discipline.
- Post-graduate training/education in a formal Regulatory or Quality Assurance program is an asset.
- Minimum five (5) years of experience within the pharmaceutical/Natural Health Product industry with a minimum three (3) years in a quality function role.
- Excellent organization and multi-tasking skills.
- High attention to detail.
- Good collaborative interpersonal skills, a positive can-do attitude, and problem-solving capabilities.
- Ability to work independently and prioritize with mínimal daily instruction.
- Proficiency in MS Office.
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