The Marihuana Quality Assurance (QA) manager works to assure that operations at the Licensed Producer(LP) meet client requirements and cGMP regulations. In addition, the manager is able to establish goals and objectives, supervise work practices for direct reports, interprets and executes policies and procedures that typically affect organizational units. This position will interact with other departments or divisions within the LP.
The QA manager will implement, enhance and manage the Quality Management System within the LP in accordance with Marihuana for Medical Purposes Regulations (MMPR). The QA manager role will entail ensuring compliance with all regulatory and corporate requirements in support of MMPR and customer expectations, by carrying out routine quality assurance and quality control tasks and activities. This position will assist in the development and execution of the company’s QA Management system, ensuring product quality and compliance with all Domestic and Global regulatory and corporate requirements. Demonstrable experience in pharmaceutical level quality including audits, batch record reviews, change control, complaint handling and investigations. Will provide oversight to the Quality Control Laboratory and testing processes.
A thorough knowledge of pharmaceutical manufacturing, packaging, testing and distribution and the associated regulatory GMP requirements, including aseptic products. Demonstrated understanding of the processes and interactions that are essential in ensuring and maintaining regulatory compliance in accordance with MMPR.
ABOUT THE JOB
Additional duties and responsibilities include: • New product development and project management review team member. • Review and release of finished products and raw materials, investigating and assessing non conformances to facilitate product dispositioning. • Internal and supplier auditing. • Work with R&D to establish and maintain specifications, test methods and acceptance criteria for product. • Team / department management.
Desired skills: • Degree or equivalent qualifications in a scientific discipline • Significant senior experience in the QA of medical technology/ pharmaceuticals, or a related regulated environment. • cGMP, cGLP, Quality Assurance and Quality Systems. • HPLC/GC/MS instrumentation • Detailed understanding of MMPR.