Sr. GM - Operations ( API - Production )

Key Responsibilities: 1. To prepare production planning as per the projection given. 2. To improve the productivity and monitor the Raw material consumptions with quality & Regulatory compliances as per cGMP requirement. 3. To monitor & ensure highest level of safety aspects during mfg. operations and handling of RM’ s / solvent handling etc. 4. To ensure the smooth operation of the plant, Review the Batch production control records before release the material, Approval of SOPs, MPCR’s and other relevant documents. 5. Responsible to assist in (But not limited to) Change control, Deviations, Non-Conformances and Market complaint. 6. To ensure the availability of Raw materials for that communicate with purchase department, generate Indents as per production planning and maintain the required inventory level of RM. 7. To communicate with R & D team for smoothly technology transfer and other product related matter. 8. To monitor the progress of new project or expansion activity in existing facility. 9. To Monitoring & control of Revenue, Capital and Man-power budget. 10. To carry out and review of self inspection and ensure compliance to action plan evolved their in. 11. To Review and approve the all relevant activities related to Engineering, Warehouse, EHS, HR & Admin, Account & IT department at site. 12. To ensure that all required legal permissions to be obtain in advance from different government, semi government department for smooth operation of all activity at site. 13. To ensure that make a good relationship with local leaders, NGOs & government officer etc. Monitor & implement companies CSR and CER activity in surrounding area for smooth operation of manufacturing activity. 14. Responsible to impact cGMP training and other trainings as required. 15. To perform the activities as per the role assigned in QEdge TMS. 16. Any other work allocated by the superior on time to time. 17. In absence of him, his job responsibility / Function as assigned above will be taken care by a manager cadre employee or employee nominated by his functional reporting head. 18. To discuss with the site QA Head regarding any notification received from regulatory authorities and communicate to corporate quality assurance head and manufacturing head 19. To follow ‘Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site. 20. To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed. 21. To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description. 22. To ensure that, In case of any event of potential data breach, it shall be handled through SOP on ‘Data Integrity.