Sobre o nosso cliente
Medical Cannabis Company focused on the cultivation, processing, extraction and research and development.
Descrição
Design, adapt and implement the company's QMS;
Develop, write, maintain, administer, train, and manage quality systems documents that can be used effectively and meet Infarmed and ISO quality system requirements;
Build an internal training program to ensure quality awareness and regulatory compliance knowledge across the company;
Responsible for and lead in all aspects of the company's compliance, in particular risk management, SDLC and design control;
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;
Plan and 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 leadership 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.
Perfil ideal
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.
Vantagens
Opportunity to join a young, dynamic and forward-looking company set to disrupt the medical cannabis space in Europe. Project of 9 months with the possibility of joining permanently the company.
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