GMP Specialist
Cronos Group View all jobs
- Stayner, ON
- Permanent
- Full-time
- Responsible for managing the implementation of GMP processes for various domestic and international customers
- Functional Subject Matter Expert for GMP within the domestic and international cannabis industries
- Supporting with on-boarding, complaints, CAPAs, and general day-to-day issues with international customers
- Lead the development and implementation of GMP processes, procedures, and documentation across warehousing, processing, packaging, and quality operations
- Create and manage project timelines, supporting cross-functional teams to hit key milestones
- Guide a cross-functional team, including manufacturing, engineering, regulatory, QA and supply chain, to execute plans on time and on budget
- Ensure GMP systems align with Health Canada Cannabis Regulations, EU-GMP requirements and any other market or customer specific GMP requirements.
- Support the integration of GMP processes to support business development and market expansion
- Create, execute, and maintain validation plans, protocols, and reports for equipment, utilities, cleaning processes, computerized systems, and manufacturing processes.
- Lead IQ/OQ/PQ activities and ensure all validation work is documented according to GMP and EU-GMP standards.
- Conduct validation lifecycle management, including periodic reviews, requalification, and revalidation.
- Support validation of new formulations, packaging formats, and process improvements.
- Lead activity to draft, revise, and maintain GMP documentation including SOPs, Work Instructions, Batch Records, Forms and any other associated materials
- Ensure documentation meets regulatory requirements and supports audit-ready operations.
- Maintain controlled documents within the Quality Management System (QMS), ensuring proper version control and traceability.
- Support internal audits, mock inspections, and regulatory inspections by preparing documentation and coordinating responses.
- Conduct risk assessments for new processes, equipment, or changes.
- Support CAPA investigations and ensure timely and effective implementation of countermeasures.
- Identify opportunities to improve GMP compliance, operational efficiency, and product quality.
- Provide GMP and validation training to operational teams.
- Work closely with QA, Production, Manufacturing, Engineering, Maintenance, and Regulatory Affairs to ensure alignment on GMP and validation requirements.
- Communicate project status, risks, and compliance considerations to leadership and stakeholders.
- Support readiness for EU-GMP certification or export-related audits.
- Degree or diploma in Life Sciences, Engineering, Quality Assurance, or a related field.
- 2–5 years of experience in a regulated industry (cannabis, pharmaceuticals, biotech, food, or natural health products).
- Demonstrated experience developing and executing validation plans, protocols, and reports (IQ/OQ/PQ).
- Strong understanding of GMP, GPP, and EU-GMP frameworks is required.
- Experience in cannabis processing, extraction, formulation, or packaging is an asset.
- Strong knowledge of regulatory requirements across North America and the EU.
- Excellent technical writing skills for validation documentation, SOPs, and quality records.
- Strong organizational and project management abilities with the capacity to manage multiple priorities.
- Proficiency with QMS platforms and standard office/project management tools.
- Detail-oriented, analytical, and able to work effectively in a fast-paced, highly regulated environment.
- Strong communication and collaboration skills.