- Ensuring the set targets of Oncology Production and deliveries OTIF are achieved as per agreed upon norms of quality, cost and efficiency. - Reviewing and planning for Plant and Machinery modifications and improvements. - Oncology Production planning in co-ordination with SCM, Sales and Marketing department. - Overall coordination with all departments for smooth functioning of operational activities. - Raw material planning with Purchase department in co-ordination with stores. - Responsible for giving objectives and responsibilities of down the line Oncology Production personnel. - Monitoring and reviewing the activities related to maintaining of Quality records and ensuring the implementation of procedures as per CGMP requirements. - Reporting of non-conformities and adherence and initiation to the corrective / preventive actions with quality assurance, senior members of Oncology Production department and other concerned departments in specific areas of operation. - Responsible for review of process related Deviations, Return goods, Market complaints, OOS, OOT, Validation protocols, Reports, APQR and Change controls. - Responsible to prepare, issue and review quality documents. - Monitor and ensure that all personnel of Oncology Production department adhering to safety, Health and Environment norms. - Establishing and Propagating EHS Management System awareness to all the personnel in the department. - Monitoring & ensuring that all departmental personnel are well guided in the preparation of departmental activity, hazard and risk assessment register, aspect /impact register and reviewing the adequacy. - Reviewing the progress/status of EHS and QMS objectives & targets periodically; reporting the progress & implementation effectiveness of the management programs to Site Head. - Monitoring, Reviewing & Ensuring all the new Projects, Oncology Oncology Productss and Processes are executed as per agreed upon timelines and Quality. - Monitoring & Ensuring Oncology Products quality by implementing and adhering to global quality standards and regulatory requirements. - Regular inspection and review of the performance of various areas of Oncology Production, and identifying the needs for development in Oncology Products yield, quality and operational efficiencies. - Costing and Budgeting: Periodic Review of Revenue Expenses, & Costs to ensure within the budget related to Oncology Production. - Review regularly and ensure adequate steps are put in place for operations of Process and Equipment with the help of OCPs and EOPs. - Approval of commercial documents like DBK statements, Job work challans, Gate pass, invoices, way bills etc. - Drive the projects undertaken by the department on regular basis. - Developing and deciding strategies on outsourced manufacturing activities. - Monitoring & Ensuring that all the set targets of OE are on time and effective. - Support Site Head in achieving the set Targets of Sales, OE, New Oncology Oncology Productss launching, Projects, Management Reports, Manpower Management, & all cost effective activities. Qualification: B Tech (Chemical) Experience: 15 to 20 years
Job Title
Lead Production - Oncology