Job Duties & Responsibilities
Quality Control (QC)
- Coordinate and oversee all activities related to directing and controlling manufacturing quality processes, ensuring compliance with client-specific and project-based quality requirements.
- Lead and conduct critical testing operations, including chemical and physical analysis of raw materials, final products, and re-released products, ensuring accurate and reliable results.
- Continuously assess and improve quality control processes, procedures, and capabilities to maintain cost-effective and efficient operations. Recommend and implement enhancements where appropriate.
- Review and ensure that all project-related quality control documentation is complete, accurate, and aligned with requirements.
- Review and approve quality documentation from contractors and subcontractors, verifying alignment with contractual and regulatory requirements.
- Manage inspection personnel and daily QC operations to maintain a safe, efficient, and compliant working environment.
- Oversee the organization and maintenance of physical resources and equipment to ensure seamless quality control operations.
- Direct QC resources and activities in alignment with project timelines and milestones.
- Lead and manage a team of skilled and semi-skilled QC professionals by implementing effective personnel practices including performance management, training, coaching, and compliance monitoring.
- Ensure all QC activities comply with Quality Assurance standards, internal procedures, client specifications, and regulatory requirements (including FDA and ISO standards).
- Liaise with the Head of Manufacturing to maintain alignment of project schedules and quality requirements across all stages of production.
Quality Assurance (QA)
- Provide QA oversight on regulatory projects including product stability changes, labeling updates, and other compliance-related activities.
- Coordinate shipments for new product launches, ensuring timely and compliant execution.
- Manage and evaluate product complaints, deviations, and CAPAs (Corrective and Preventive Actions), including trend analysis and process improvements.
- Develop, revise, review, and implement Standard Operating Procedures (SOPs) in line with quality and regulatory requirements.
- Conduct annual product reviews and assess stability reports to ensure compliance with Canadian product registrations.
- Collaborate with Compliance and RAQA Specialists to maintain and update quality agreements with manufacturers, wholesalers, and distributors.
- Conduct inspections of third-party distributors and wholesalers in accordance with GMP standards.
- Serve as the primary QA contact for Third Party Logistics (3PL) providers, and act as the qualified person for internal quality compliance.
- Implement product recall procedures when necessary and conduct annual mock recalls to validate recall readiness.
- Monitor warehousing and shipping practices for compliance with procedural manuals and regulatory expectations.
Additional Responsibilities
- Foster and maintain a customer-focused culture across the organization.
- Support the development and achievement of quality goals and objectives aligned with the company's strategic direction.
- Carry out additional tasks and responsibilities as reasonably assigned by management in support of the organization's goals and interests.
