Engineering and Maintenance
• 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.
Required Education Qualification: Bachelor of Engineering
Required Experience: 20 to 25 years
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