Reporting to the Head of Quality, the Quality Assurance Supervisor will be responsible for supervising the Quality Assurance Systems, Operations, and Validation for Cannabis Products. The role involves supporting the implementation and monitoring of Tilray Portugal's Quality Management System to ensure regulatory compliance and business goals are met.
The supervisor will oversee quality assurance systems for medical cannabis, ensuring strict compliance with GMP, GACP, CUMCS standards, and other guidelines. They will lead the quality assurance team, working closely with production and support teams to maintain quality standards across all operations.
Responsibilities
1. Implement, maintain, and monitor quality systems to ensure product quality, safety, efficacy, and compliance.
2. Ensure proper documentation for production, testing, and storage processes.
3. Supervise daily quality assurance operations, including resource management.
4. Monitor validation activities and support protocol and report reviews.
5. Ensure compliance with Portuguese legislation, GMP, GACP, and other standards, leading corrective actions as needed.
6. Support regulatory and client audits.
7. Oversee production monitoring and communicate results to stakeholders.
8. Review SOPs, instructions, and specifications.
9. Conduct internal and external audits, address non-compliances, and collaborate on corrective actions.
10. Implement and monitor self-inspection programs.
11. Manage change control, deviation investigations, and CAPA processes, ensuring timely completion and notification.
12. Support complaint investigations, including root cause analysis.
13. Lead investigations into quality issues, proposing corrective actions and documenting deviations.
14. Review batch records, ensuring adherence to GACP and GMP requirements.
15. Supervise annual product quality reviews and document control management.
16. Manage supplier qualification and monitor outsourced activities.
17. Evaluate and manage new business opportunities, including client qualification and audits.
18. Conduct risk assessments and reviews.
19. Drive continuous improvement of quality systems, operations, and validation processes.
20. Support project quality requirements and monitor data trends for non-compliances.
21. Establish and report on KPIs and relevant metrics monthly.
22. Oversee pest management programs and interface with international quality teams.
23. Support R&D processes and ensure effective communication of quality issues.
24. Assist with product registration processes.
25. Monitor team performance, maintain a safe and compliant workplace, and address quality issues.
26. Coordinate work activities with other departments, resolve problems, and recommend efficiency improvements.
27. Lead conflict resolution, ensure policy adherence, and promote team motivation.
28. Coordinate resource utilization and ensure compliance with standards for cost, waste, quality, and safety.
Qualifications and Requirements
* Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biology, or related field.
* At least three years of experience in quality assurance operations or systems.
* Experience in GxP-regulated industries or cannabis industry is a plus.
* Proficient in Microsoft Office applications.
* Fluent in English communication.
* Strong management and communication skills.
* Ability to multitask with minimal supervision.
* Excellent writing and analytical skills.
* Ability to work with cross-functional teams and develop metrics and audits.
* Proven problem-solving skills and a strong work ethic.
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