Do you have passion for what you do? Are you self-motivated, results-driven and like working in a collaborative and team environment? Do you want to learn and grow with Purplefarm Genetics as we learn and grow with you? Then we have a position for you!
Purplefarm Genetics is one of Canada’s premier craft cannabis producers. Coming from the legacy market, Purplefarm Genetics currently operates a 12,000 sq ft facility out of Johnstown, Ontario and expanded into Fredericton, New Brunswick to operate a 90,000 sq ft facility.
We are looking for an EUGMP Project Lead to support our ongoing efforts of certification and to support as an AQAP.
Your duties shall include, but are not limited to, the following:
EU-GMP Project:
· Lead and coordinate all activities related to achieving and maintaining EU-GMP certification.
· Serve as the primary quality representative for EU-GMP certification projects, inspections, and regulatory interactions.
· Review and assess existing quality systems, procedures, and records to ensure alignment with EU-GMP requirements.
· Conduct gap assessments against EU-GMP standards and develop remediation plans to address deficiencies.
· Collaborate with cross-functional departments to implement EU-GMP compliant processes and practices.
· Develop, revise, and approve quality documents required for EU-GMP compliance, including SOPs, validation protocols, reports, and quality agreements.
· Oversee and support qualification and validation activities, including equipment, utilities, computerized systems, cleaning, and process validation.
· Coordinate and participate in internal audits to assess readiness for EU-GMP inspections.
· Track and monitor corrective and preventive actions (CAPAs) arising from audits, assessments, and compliance reviews.
· Support supplier and service provider qualification activities required for EU-GMP certification.
· Ensure training programs meet EU-GMP requirements and coordinate training related to EU-GMP standards.
· Review quality metrics and compliance trends to identify potential risks to certification readiness.
· Participate in risk assessments and quality risk management activities in accordance with EU-GMP expectations.
· Support batch record review processes and quality oversight activities as required for EU-GMP compliance.
· Coordinate inspection readiness activities, including preparation of documentation, responses to auditor requests, and inspection logistics.
· Assist with the development and maintenance of the Site Master File and other regulatory documentation required for certification.
· Monitor updates to EU-GMP regulations, guidelines, and industry best practices and assess impacts on the organization's compliance program.
· Ensures that all cultivation and processing activities are carried out as per Standard Operating Procedures (SOP), at all times.
· Comprehensive understanding of the Cannabis Act and its Regulations, along with provincial regulations related to cannabis. Must understand the regulatory frameworks and will work with other departments to ensure compliance.
· Collaborate with other relevant departments such as operations, sales and marketing to ensure compliance with Health Canada regulations and guidelines.
· Prepare and support responses to audit observations, inspection findings, and regulatory commitments.
· Provide regular updates to COO on certification progress, compliance risks, and project milestones (2 x per week).
· Act as a subject matter expert on EU-GMP requirements and provide guidance to departments on compliance-related matters.
· Other duties as assigned.
Key Deliverables
· Successful EU-GMP certification and inspection outcomes.
· Closure of identified EU-GMP gaps and CAPAs.
· Completion of validation and qualification programs.
· Inspection-ready quality documentation and records.
· Ongoing compliance with EU-GMP standards and expectations.
· Development of a sustainable EU-GMP quality culture across the organization.
Qualifications:
· Bachelor's degree in Science, Pharmacy, Microbiology, Chemistry, Biology, or a related discipline (or equivalent combination of education and experience).
· Minimum 3–5 years of Quality Assurance experience in a regulated industry (pharmaceutical, cannabis, biotechnology, medical device, or food manufacturing), with direct involvement in EU GMP/GMP quality systems.
· Demonstrated knowledge of EU GMP, Health Canada Cannabis Regulations, Good Production Practices (GPP), and ICH guidelines.
· Experience supporting or leading EUGMP certification projects, regulatory inspections, customer audits, and CAPA management.
· Strong understanding of quality systems, including change control, deviations, investigations, risk assessments, document control, validation, supplier qualification, and training.
· Experience reviewing and approving controlled documents, batch records, SOPs, validation protocols, and quality records.
· Excellent organizational, analytical, and problem-solving skills with the ability to manage multiple priorities and meet project timelines.
· Strong communication and leadership skills with experience training employees and collaborating cross-functionally with Production, Cultivation, Operations, and Quality teams.
· Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS)
· Ability to work independently while maintaining a high level of attention to detail, integrity, and commitment to continuous improvement.
Pay: $75,000.00-$105,000.00 per year
Benefits:
- Casual dress
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Vision care
- Work from home
Work Location: In person
