compensation: 50K-60K Annually, plus full medical benefit and annual bonus employment type: full-time
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Nutraceutical company looking for QA/RA Specialist. Candidate is responsible for maintaining and supporting the Quality Management System to comply with relevant national and international standards and regulations.
Generate various QA related documents control: Creation, revision, review, approval and control of documents
Maintaining Master SOP Binders and Area Production Binders. Revision of (SOPs) Standard Operating Procedures. Ensure document control completeness and conduct and assist internal and external audits. Serve as site representative
Ensuring Senior Management is up to date on medical device regulatory requirements, and ensure required changes or updates are implemented
Ensuring all facility and product registrations are current
Preparation of documents and submission for Health Canada product registration. Internal audit process and to coordinate external audits
Proactively develops and maintains the company’s Quality Management System in accordance with regulatory and corporate requirements.
Works closely with the production facility to ensure adequate quality controls are undertaken.
Monitoring and verification of qualification and validation processes to ensure compliance with written protocols and regulatory requirements.
Supports new product development, risk analysis and launch processes, and manage QA participation in new product development.
Conduct quality management system process audit for compliance, effectiveness, and continued alignment with applicable regulatory and statutory requirements.
Identify and initiate improvements to the quality management system, ensuring compliance to all relevant quality standards and regulatory requirements.
Coordinate quality inspections/audits and their follow ups for self-inspection, Regulatory Authority audits, and inspection of external partners;
Preparation of regulatory dossiers of new products and their submissions to regulatory authorities, as well as maintaining the life cycle of our current products;
Maintain and archive regulatory documentation for assigned projects/products (as appropriate);
Other duties as required.
Recognized Degree in Relevant Field
4 or more years of relevant experience (or demonstrated abilities)
Working knowledge in Regulatory Affairs and Quality Assurance regulations and guidelines, SOP administration, GMPs, and international regulatory practices and bodies (Health Canada, FDA).
Excellent organizational, project management, and time management skills.
High level of accuracy and strong attention to detail.
Strong communication skills (both written and verbal)
ERP experience is a plus.
QA/RA: 4 year (Preferred)
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