Under-License Manufacturing and Technology Transfer Coordinator

Job Description

KEY ACCOUNTABILITIES: Your responsibilities include, but are not limited to: ● Being present in contract manufacturing companies during manufacturing periods for coordination and supervision of under-license manufacturing and establishing good working relationships (currently approx. 5 days/month travel in Iran). ● Ensuring the implementation of GXP and Quality Assurance principles during manufacturing operations and in accordance with the Quality Agreement. ● Participating in the documentation of batch records and any quality events. ● Ensuring that the Technology Transfer and Local Manufacturing QA Manager, and Regulatory Manager are kept informed of all critical and major issues which may have an adverse effect on the quality of the product. ● Collaborating with Technology Transfer and Local Manufacturing QA Manager in providing direction and support to contract manufacturing companies and to ensure that they are qualified, achieve a high level of competence, and are motivated to carry out their duties to ensure that the products meet Rougine Darou and Licensor quality, efficacy and safety requirements. ● Accompanying the team in contract manufacturing sites and suppliers during audits, continuous improvement activities, or to resolve any issues. ● Providing input and reports to regulatory, commercial/sales, and financial departments on manufacturing status and amounts. ● Assisting in setting up and improving Pharmaceutical Quality Management System in Technology Transfer and Local Manufacturing QA. ● Reporting to the Technology Transfer and Local Manufacturing QA Manager.