Tilray is a federally licensed producer of medical cannabis. We are committed to setting the gold standard of care and excellence in our industry. We believe that commitment starts with a great work environment and benefits for our associates.
Looking to develop your career at the forefront of a rapidly expanding industry?
Ready to apply your talents to make a positive difference in the lives of patients across the country?
GMP AUDITOR, GLOBAL QUALITY, TORONTO, ON
Reporting to the Global Third Party Coordinator, GMP Auditor independently performs quality audits of licensed producers of Cannabis, suppliers of API, excipients, packaging components, and firms providing GMP services such as laboratories and others as required, to ensure products and services meet quality standards. Prepares audit reports and communicates findings to external and internal stakeholder. Able to act completely independently as a Quality auditor.
Role and Responsibilities
- Independently conducts external audits, acting as Lead Auditor of an audit team, or participating as an external audit team member.
- Provide GMP expertise and experience to Tilray Inc. on the status of compliance of the audited firm(s) for the scope of service/product sourced.
- Maintain audit schedule, communicate with the auditee and develop audit agenda.
- Independently perform evaluations of quality systems and practices in compliance with (GMP, ICH, CFR, IPEC, GACP, etc.), coordinates resolutions, and provides guidance on quality/compliance risk levels.
- Prepares audit reports and communicates findings to external and internal stakeholders.
- Tracks audit responses and auditee’s CAPA until completion and closeout.
- Participates in the development of QA programs, policies, procedures and controls.
- 5+ years of relevant experience in the pharmaceutical industry and a BS or BA.
- Minimum 3 years direct auditing experience in the pharmaceutical or biotechnology industry.
- Strong knowledge of the requirements of ICH Q10 (plus ICH Q8 and ICH Q9)
- Strong knowledge of GxP legislation and guidance e.g. Eudralex Volume 4, 21 CFR (pertaining to cGMPs).
- Knowledge and experience working within a pharmaceutical manufacturing, packaging, and/or warehousing cGMP Quality Management System.
- Knowledge of the Canadian Access to Cannabis for Medical Purposes Regulations, Cannabis Act and Regulations, Food and Drugs Act and Regulations, Controlled Drugs and Substances Act and Regulations
- Ability to assess risk using Quality Risk Management tools and advise senior management on risk mitigation strategies.
- Professional auditor certification is desirable e.g. Certified Quality Auditor (ASQ)
- Excellent communication skills - written and verbal.
- Fluent in English, additional language is a plus.
- Travel approximately 60%