Production _ Injectable Plant

Job Description

Qualification - B. Tech, Any Graduate Relevant Experience : 4 to 14 Years RESPONSIBILITIES: 1. To plan production activity based on production schedule. 2. To ensure that the raw materials and packing materials indents are received from QA and given to stores well in advance to meet the production schedule. 3. To ensure that the raw materials and packing materials are received in time from stores to avoid down time. 4. To co-ordinate with Engineering department and ensure that the preventive maintenance of all machineries are done on planned preventive maintenance day. 5. To co-ordinate with inspection section and get the trend of rejections and to initiate appropriate corrective actions. 6. To ensure discipline in the section, to practice cGMP at every stages of production. 7. To identify the training requirements of officers working in the section and to impart training to officers working in production section. 8. To ensure high yield and maximum productivity. 9. Conduct periodic internal review or audit to ensure the compliance. 7. Evaluating the efficiency of controls and improve the quality continuously. 8. Collaborate with cross functional team to monitor enforcement of standards and regulation. 9. Review the work of down level employees when necessary to identify compliance issues and provide the training. 10. Keep abreast of regulatory developments within the department as well as evolving best practices in compliance control. 11. Daily GEMBA within the department to ensure the compliance. 12. To run the department in a cost effective manner. 13. Co-ordination with other departments. 14. To train the employees and officers on aseptic culture and the importance of following aseptic culture in a pharmaceutical manufacturing unit producing injectable. 15. To ensure that the stationery/consumables required for the plant is indented/made available in time. 16. To raise deviation/incident and change controls, as applicable. 17. To ensure proper housekeeping in the department. 18. To ensure that the operators and officers are strictly following systems and SOPs at every stage. 19. To put proposals for continuous improvement of the plant operations. 20. To ensure that the equipment and machineries used in the plant are validated/revalidated in time by proper co-ordination with Engineering and QA departments. 21. To co-ordinate and execute the validation for new equipment. 22. To ensure that all technical aspects and qualitative measures are strictly followed/ensured in every batch production. 23. To monitor aseptic process simulation study and batch activities at all the stages. 24. To ensure documentation and control on documents. 25. To make recommendation for automation of the unit/activity. 26. To practice Quality Management System at every stage of the work. 27. To report to Production - Manager. Thanks & Regards Praveen Kumar M ****************************** E-mail : praveenkumar@bvrpc.com