Our Client wants to hire a Quality Assurance Specialist. This person will work closely with all cross-functional areas of the organization and external resources to maintain the company's Quality Management System (QMS), develop all the required Standard Operating Procedures (SOPs) and attain all required regulatory certifications/approvals.
Description
- Implement the company's QMS;
- Maintain, administer, train, and manage quality systems documents that can be used effectively and meet Infarmed and ISO quality system requirements;
- Responsible for the company's compliance;
- Provide counsel, training, coaching and interpretation of quality assurance requirements and Infarmed and other regulatory guidelines or issues to company personnel;
- Act as a liaison between the company and regulatory authorities;
- Ensure the proper interface of the CQA function to cultivation, product development, commercialization, manufacturing, supply chain, and other areas as required;
- Prepare document packages for submission to global regulatory agencies;
- Foster a strong relationship, partnership and advocacy with Infarmed and Global Health authorities, as it relates to innovation in cannabis;
- Monitor proposed and current relevant EU regulations and guidance and advise;
- Provide Quality Assurance for Good Manufacturing Practices (GMP) product quality systems and activities;
- Support and guide throughout the project, ensuring high quality expectations are met and technical readiness requirements are met in all phases of development.
Profile
- Master's degree with a focus in Life Sciences or equivalent;
- Experience in QA within the Pharmaceutical / Medical cannabis industry;
- Experience developing, improving and maintaining Infarmed and ISO compliant quality management systems;
- Knowledge and experience with external standards: ISO 9001, ISO 13485, IEC 62304, ISO 14971 and 21 CFR 820 (FDA cGMP/QSR), especially pertaining to product development, manufacturing, supplier management, quality control and customer complaints;
- Expert knowledge in advanced CQA systems, including the establishment of relevant CQA metrics;
- Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details.
Job Offer
Opportunity to join a young, dynamic and forward-looking company set to disrupt the medical cannabis space in Europe. PERMANENT POSITION.