Quality Assurance Supervisor, Cantanhede Reporting to the Head of Quality, the Quality Assurance Supervisor will be responsible for the supervision of the Quality Assurance Systems, Operations and Validation for Cannabis Products. The Quality Assurance Supervisor will supervisor and support the successful implementation and monitoring of Tilray Portugal Quality Management System in pursuance of regulatory compliance and achievement of business goals. The Quality Assurance Supervisor will support the implementation and ongoing monitoring of the quality assurance systems for medical cannabis in strict compliance with GMP, GACP, CUMCS standard and other applicable guidelines. The Quality Assurance Supervisor will supervise the quality assurance team and work closely with production (cultivation & manufacturing) and support teams to ensure that quality standards are established, implemented and maintained throughout all operations. Responsabilidade / Role and Responsabilities
1. Implement, maintain and monitor the effectiveness of quality systems within company to ensure product quality, safety and efficacy and regulatory compliance
2. Ensure that products are produced, tested and stored according to appropriate documentation in order to obtain the required quality
3. Supervise Quality Assurance day to day operations including resource allocation and schedules
4. Monitor and supervise the Validation activities
5. Support the elaboration and review Validation Protocols and Reports
6. Monitor all relevant data for compliance to Portuguese legislation, GMP, GACP guidelines & other jurisdictions and lead corrective action required
7. Support and host regulatory and client audits
8. Lead monitoring and control in production (cultivation and manufacturing) process and support areas (warehouse, facilities, etc…) and communicates results to respective area stakeholders
9. Elaborate and review SOPs, instructions, specifications and other relevant documentation
10. Perform internal and external audits, monitoring and communicate non-compliances and collaborate with respective departments on corrective actions
11. Support and monitor the Self-Inspection program implementation
12. Management of the Change Control Program, Deviation Investigation Processes and Corrective and Preventative Action (CAPA) implementation. Ensure all reports are completed in timely manner; provide timely notification to the responsible persons
13. Support Complaints processes including Root Cause Analysis (RCA) and investigation
14. Lead investigation activities associated with problems or failures within the overall quality systems, to analyze root cause, to propose appropriate corrective action, and to document with deviation reporting tools;
15. Perform and supervise batch record review
16. Ensure Batch Records are being maintained and GACP & GMP requirement are being adhered to for all operations
17. Supervise completion of annual Product Quality Review
18. Document Control Management ensuring adequate retention records and data integrity
19. Manage and maintain the Supplier and Service Provider Qualification program ensuring the monitoring of suppliers of materials, contract manufacturers and providers of other GMP & GACP related outsourced activities – including audit performance, reporting and QAG elaboration and revision.
20. Manage and maintain the evaluation and management of new business opportunities – including Client qualification, audit and CAPA, and QAG elaboration and revision.
21. Risk Assessment Analysis – elaboration and review
22. Lead the continuous improvement of Quality Systems, Operations and Validation
23. Support quality requirements for projects
24. Monitor data trends and communicates non-compliances to respective Head of Quality and Senior Leadership
25. Establish, communicate and report monthly KPI and other relevant metrics
26. Monitor and supervise pest management program
27. Interface with international quality
28. Support to R&D process
29. Ensure a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management
30. Assist Regulatory Affairs department during product registration
31. Monitor the performance of quality employees within department
32. Maintain a safe, clean and legally compliant workplace
33. Identify, investigate, correct and document potential quality and compliance issues
34. Establish methods to meet work schedules and co-ordinate work activities, with other departments
35. Resolve work problems and recommend measures to improve efficiency and product quality
36. Motivate members through the setting of clear expectations
37. Coordinate with other supervisors, leads, and managers to obtain maximum use of resources
38. Ensure compliance with company standards for cost control, waste reduction, quality, safety, and complete and on-time delivery
39. Provide leadership for problem and conflict resolution
40. Maintain and adhere to all company policies and procedures
Qualificações e Requisitos / Qualifications and Education Requirements
41. Must have degree in Chemistry, Chemistry Engineer, Pharmaceutical, Biology or similar;
42. Three years of professional experience in quality assurance operations and/or systems;
43. Experience in a GxP regulated industry and/or Cannabis industry is a plus;
44. Proven ability to effectively use Microsoft Office Applications;
45. Can communicate and comprehend English language is required;
46. Strong management skills required;
47. Must possess excellent communication skills for liaising and communicating staff, vendors, and other departments;
48. Highly capable of multi-tasking, with minimal supervision;
49. Good writing skills;
50. Extremely detail-oriented and analytical thinker;
51. Able to interface directly with cross functional teams;
52. Able to develop, review, and maintain metrics and audits;
53. Proven problem identification skills;
54. Strong work ethic and positive team attitude.