Job Description
Position Summary:
The Quality Assurance and Compliance Specialist is responsible for ensuring the development, implementation, and continuous improvement of quality management systems and validation protocols in compliance with U.S. FDA and Health Canada GMP regulations, ISO 22716 (GMP for Cosmetics), and ISO 9001:2015 (QMS) . This role supports regulatory compliance, product quality, and operational excellence through meticulous documentation, inspection, and cross-functional collaboration.
Key Responsibilities:
- Quality Management & Regulatory Compliance:
- Develop and implement quality management and validation protocols aligned with U.S. FDA, Health Canada, ISO 22716, and ISO 9001:2015 standards.
- Ensure ongoing compliance with cGMP requirements and industry best practices.
- Documentation & Recordkeeping:
- Maintain accurate and complete batch records and quality documentation.
- Review and approve batch production records to ensure compliance with SOPs and regulatory standards.
- SOP Development & Validation:
- Create, review, and update Standard Operating Procedures (SOPs) related to validation, calibration, and other quality processes.
- Ensure SOPs reflect current regulatory updates and best practices.
- Quality Inspections & Product Release:
- Conduct inspections of incoming raw materials and packaging components to verify conformance to specifications.
- Perform in-process and final product quality checks to ensure compliance with defined specifications and regulatory requirements.
- Deviation Management & CAPA:
- Document, investigate, and report non-conformances and deviations.
- Support root cause analysis and implement corrective and preventive actions (CAPAs) in collaboration with cross-functional teams.
- Continuous Improvement:
- Identify opportunities to enhance quality systems and processes.
- Propose and implement improvements to ensure product quality and regulatory compliance.
- Audits & Regulatory Support:
- Lead preparation for internal and external audits, including Health Canada and FDA inspections.
- Assist in the development of site license application packages and regulatory submissions.
- Regulatory Monitoring:
- Stay current with U.S. FDA, Health Canada NNHPD, and CFIA guidelines and updates.
- Ensure all products and processes remain compliant with evolving regulatory requirements.
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