Job Description

•Main Objective: As a Responsible Pharmacist, you will be responsible for ensuring that a particular batch has been manufactured in accordance with its marketing authorization, EU Good Manufacturing Practice (GMP) and local requirements. •Main responsibilities: -Ensure that QA Manager and Factory Management is informed about non-conformities that tentatively might be classified as major or potential recalls -Participate in the planning, carrying out and following up of inspections, audits and internal inspections within field of responsibility -Authorized to delegate certification and release of batches of medicinal products to QP delegates in the department -Participate in audit of Novo Nordisk contract manufacturer or delegate to QP delegates -Participate in quality review meetings at CMO’s or delegate to QP delegates -Quality assurance in relation to establishment, approval and monitoring of contract manufacturers world wide -Ensure license to operate, GMP compliance and audit/inspection performance at contract manufacturers -Appointing and approve QP delegates in Local Manufacturing Tehran -Establish and maintain list of QP delegates within Local Manufacturing Tehran -Review and approve job description of QP delegates in Local Manufacturing Tehran -Approving QP delegates access to IT release systems -Review and approve procedures for batch status assignment (Confirmation and certification) -Review and approve Novo Nordisk APR report -Once a year, randomly check certification for release carried out by QP delegate, and the certification/release process