The Quality Assurance and Control Manager is responsible for ensuring that production operations comply with regulatory standards and industry best practices. They develop and implement quality strategies aligned with Pharmaflorx’s objectives while maintaining the integrity of the quality system and optimizing processes to ensure maximum efficiency and compliance.
Key Responsibilities:
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Quality Strategy and System Implementation
- Define and implement a quality strategy in line with Pharmaflorx’s values and objectives, integrating industry trends and regulatory requirements.
- Ensure compliance with applicable standards and regulations (Health Canada, GACP, GMP, etc.) by overseeing the implementation, effectiveness, and integrity of the quality system.
- Develop and update quality assurance and control procedures to ensure optimal and compliant operations.
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QA/QC Team Management and Development
- Recruit, train, and oversee quality assurance and control (QA/QC) teams.
- Promote a strong quality culture across all levels of the company by training and raising awareness among staff regarding quality requirements and best practices.
- Supervise the development and approval of products for both domestic and international markets.
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Process Optimization and Quality Improvement
- Conduct audits of standard quality assurance procedures to identify opportunities for improvement and optimization.
- Develop and oversee continuous improvement plans to maximize efficiency while ensuring regulatory compliance.
- Establish and monitor key quality performance indicators and implement corrective actions when deviations occur.
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Regulatory Compliance and Validation
- Review and approve quality documents required for regulatory submissions to Health Canada and other relevant agencies.
- Ensure the validation and qualification of equipment, facilities, and systems according to industry standards (e.g., master validation plan, process and equipment validation protocols).
- Assess and manage quality risks by implementing an effective risk management plan.
Required Profile:
- Experience: Minimum of 5 years in quality assurance and control, ideally in the pharmaceutical, biotechnology, or cannabis industry.
- Technical Knowledge: Strong understanding of regulations and standards (Health Canada, GMP, GACP), as well as validation and qualification processes.
- Analytical Skills: Ability to audit, analyze, and optimize quality processes while implementing effective improvements.
- Leadership and Team Management: Proven experience in supervising and training quality teams.
- Organization and Attention to Detail: Strong ability to manage multiple projects simultaneously while ensuring compliance with standards and deadlines.
- Communication and Collaboration: Ability to work cross-functionally with various departments to integrate and reinforce a quality-driven culture within the company.
This role is an excellent opportunity for a quality expert seeking to grow in an innovative and rapidly expanding environment.