SENIOR DIRECTOR

Department Details Engineering and Maintenance Role Summary Costing and budgeting for the department. To ensure all the legal requirements are met and initiate suitable action in the event of discrepancy noted. Interact with regulatory authorities with matters concerning the legal requirements. Co-ordination for audits (internal and external) related to QMS and EHS management system. Non-conforming products and corrective actions-implementation as suggested by Quality Assurance. Adherence to standard operating procedures, Safety, cGMP, cGLP and EHS requirements. Implementation of energy conservation measures. Identification of training needs in the department. Inventory management. Ensure all equipment’s are operated and maintained as per manufacturer’s recommendation. Planning and procurement of spares and consumables. Authorized to review P&IDs, PFDs, Layouts and other drawings. Preparation and reviewing documents/records related to QMS and EMS under SMV facility. Monitoring of the projects initiated from the department on regular basis. Approval of commercial documents. Planning and execution of different types of maintenance of equipment and its accessories in co-ordination with users. Review the change control changes related to engineering & maintenance department. Review the Qualification & re-qualification protocols and reports. Review of Risk Assessment Protocol, Reports and FMEA. Review of CAPA initiation & Closure (With Respectto Audits, OOS, OOT, Errata & Deviations). Errata’s review and follow up the closures. Review of periodical validations for air handling units as per periodical schedule. SAP Activities. Review of SOP’s, EOP’s, OCP’s and related annexures (Revision / New procedure). Review the Annual / Quarterly Planners. Responsible for Mechanical, Electrical, Instrumentation, Utility maintenance and operation related QMS activities. Authorizing the procurement activities and ensuring compliance in the Procurement. Key Responsibilities Costing and budgeting for the department. To ensure all the legal requirements are met and initiate suitable action in the event of discrepancy noted. Interact with regulatory authorities with matters concerning the legal requirements. Co-ordination for audits (internal and external) related to QMS and EHS management system. Non-conforming products and corrective actions-implementation as suggested by Quality Assurance. Adherence to standard operating procedures, Safety, cGMP, cGLP and EHS requirements. Implementation of energy conservation measures. Identification of training needs in the department. Inventory management. Ensure all equipment’s are operated and maintained as per manufacturer’s recommendation. Planning and procurement of spares and consumables. Authorized to review P&IDs, PFDs, Layouts and other drawings. Preparation and reviewing documents/records related to QMS and EMS under SMV facility. Monitoring of the projects initiated from the department on regular basis. Approval of commercial documents. Planning and execution of different types of maintenance of equipment and its accessories in co-ordination with users. Review the change control changes related to engineering & maintenance department. Review the Qualification & re-qualification protocols and reports. Review of Risk Assessment Protocol, Reports and FMEA. Review of CAPA initiation & Closure (With Respectto Audits, OOS, OOT, Errata & Deviations). Errata’s review and follow up the closures. Review of periodical validations for air handling units as per periodical schedule. SAP Activities. Review of SOP’s, EOP’s, OCP’s and related annexures (Revision / New procedure). Review the Annual / Quarterly Planners. Responsible for Mechanical, Electrical, Instrumentation, Utility maintenance and operation related QMS activities. Authorizing the procurement activities and ensuring compliance in the Procurement. Educational Qualifications Required Education Qualification: Bachelor of Engineering Required Experience: 20 to 25 years