Job Description

1. Directly responsible for managing and coordinating all manufacturing activities 2. Responsible for ensuring and enforcing compliance with cGMPs, site-specific policies, and procedures as per Eudralex Vol IV and ICH guidelines 3. Responsible for maintaining and reporting the performance of the department to the Operation Manager. 4. Responsible for the professional development and mentoring of direct reports. 5. Directly responsible for production schedule adherence and material consumption rates. 6. Responsible for all safety incidents and quality deviations that occur and responsible for the thorough investigation and timely reporting of such. 7. To ensure the qualification and maintenance of his department, premises and equipment; 8. To ensure that the appropriate validations are done; 9. To participate in technology transfers 10. Responsible for authorization of written procedures and other documents, including amendments. 11. Responsible for supervision of plant hygiene. 12. Participate in qualification of contract manufacturers and providers of other GMP related outsourced activities in the scope of his duties. 13. Responsibility for the designation and monitoring of storage conditions for materials and products together with the Warehouse Assistant Manager. 14. The retention of relevant records. 15. To participate in the design, implementation, monitoring, maintenance and advocate continual improvement of an effective pharmaceutical quality system 16. To demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization related to his obligations 17. participate in establishment of a quality policy that describes the overall intentions and direction of the company related to quality should determine 18. Ensuring that a timely and effective communication and escalation process exists to raise quality issues 19. Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement 20. Any of the above duties can be delegated without any revocation of responsibility 21. Any other duties assigned by the Board of Directors related to the pharmaceutical industry