Compliance & Quality Assurance Manager - Medical Cannabis (m/f)Referencia: JN -********
Adicionado em 31.10.2024
Sobre os nossos clientes
Medical Cannabis Company focused on the cultivation, processing, extraction and research and development. Descriçao da oferta We are looking for a Compliance & QA Manager to oversee our client's Compliance & QA strategy and activities. This person works 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 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. 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. Project of 9 months with the possibility of joining permanently the company.
O que procuramos
Quality Assurance, Compliance, Medical Cannabis
Contacto da Michael Page
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