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 / Recent 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.

- 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

📌 Senior Director (India)
🏢 BIOCON PHARMA
📍 India