Manager-Plant Maintenance Engineer Injectable

Akums Drugs & Pharmaceuticals Limited; Haridwar; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Akums Drugs & Pharmaceuticals Limited in Uttarakhand, Haridwar invites an Engineering Manager to oversee the injection unit's maintenance, utility management and cost control. The role focuses on implementing automation, optimizing efficiency and ensuring compliance with cGMP and ISO standards.

You will lead maintenance planning, coordinate with QA, HR and EHS, review budgets, approve CAPEX requests, and drive preventive maintenance, calibration, and SOP updates to keep the plant running

Responsibilities

• Review, monitor and control daily utility consumption and engineering expenses to ensure efficiency and cost management.
• Review and present the annual engineering maintenance budget to management for approval.
• Responsible for introducing and executing automation systems to optimize costs, quality, and productivity of injectable unit.
• Establish an autonomous system to reduce breakdowns and adopt new technologies to upkeep all machines trouble-free.
• Establish energy-saving initiatives and implement energy conservation projects to enhance efficiency and sustainability.
• Ensure compliance with EU, WHO & ISO 50001:2018 (Energy Management System), 14001:2015 (Environmental Management System), 9001:2015 (Quality Management System) & ISO 45001:2018 (Occupational Health & Safety).
• Ensure compliance with environmental parameters, maintaining them within prescribed limits as per norms and guidelines.
• Ensure uninterrupted availability of required utilities to support plant production, quality control, warehouse operations, and other departments.
• Responsible for smooth functioning of all engineering activities and ensure timely delivery of engineering services.
• Manage all modification and up gradation projects, ensuring effective coordination with departments and management.
• Review, approve, and coordinate the execution of AMC/CMC activities to ensure timely and effective implementation.
• Ensure timely approvals of SAP, SWS, CAPEX, Bills, Asset Transfer request etc.
• Ensure to review and up gradation of operation and maintenances SOPs as per cGMP approach.
• Ensure for proper review and verification of QMS documentation like Change control, CAPA, Incident, RCA, Investigation, RA, and Deviation.
• Ensure timely and effective implementation of preventive maintenance as per planner.
• Ensure to review the calibration activity and protocol reports of engineering and other departments.
• Ensure all engineering departmental training and development shall be done as per cGMP guidelines and standard operating procedures applicable for injection dosages form.
• Ensure to update all compliances on time in coordination with HR & EHS department.
• Ensure to participate, review and comply all regulatory audits. (Internal, external & self-inspection).
• Ensure execution support to concern department & QA during qualification and validation activities of injection unit.
• Ensure proper co-ordination with cross-functional team.
• Ensure to create positive learning atmosphere within the team.
• Ensure timely preparation and submission of ORM and MRM data to management.

Job description

• 1. Review, monitor, and control daily utility consumption along with engineering expenses to ensure efficiency and cost management.
• 2. Review and present the annual engineering maintenance budget to management for approval.
• 3. Responsible for introducing and executing automation systems to optimize costs, quality, and productivity of injectable unit.
• 4. Ensure to establish the autonomous system to reduce breakdown & approach to implement new technology and systems to upkeep all machines trouble free.
• 5. Establish energy-saving initiatives and implement energy conservation projects to enhance efficiency and sustainability.
• 6. Ensure to review and comply as per EU, WHO & ISO 50001:2018 (Energy Management System), 14001:2015 (Environmental Management System), 9001:2015 (Quality Management System) & ISO 45001:2018 (Occupational Health & Safety).
• 7. Ensure compliance with environmental parameters, maintaining them within prescribed limits as per norms and guidelines.
• 8. Ensure uninterrupted availability of required utilities to support plant production, quality control, warehouse operations, and other departments.
• 9. Responsible for smooth functioning of all engineering activities and ensure timely delivery of engineering services.
• 10. Manage all modification and up gradation projects, ensuring effective coordination with departments and management.
• 11. Review, approve, and coordinate the execution of AMC/CMC activities to ensure timely and effective implementation.
• 12. Ensure timely approvals of SAP, SWS, CAPEX, Bills, Asset Transfer request etc.
• 13. Ensure to review and up gradation of operation and maintenances SOPs as per cGMP approach.
• 14. Ensure for proper review and verification of QMS documentation like Change control, CAPA, Incident, RCA, Investigation, RA, and Deviation.
• 15. Ensure timely and effective implementation of preventive maintenance as per planner.
• 16. Ensure to review the calibration activity and protocol reports of engineering and other departments.
• 17. Ensure all engineering departmental training and development shall be done as per cGMP guidelines and standard operating procedures applicable for injection dosages form.
• 18. Ensure to update all compliances on time in coordination with HR & EHS department.
• 19. Ensure to participate, review and comply all regulatory audits. (Internal, external & self-inspection).
• 20. Ensure execution support to concern department & QA during qualification and validation activities of injection unit.
• 21. Ensure proper co-ordination with cross-functional team.
• 22. Ensure to create positive learning atmosphere within the team.
• 23. Ensure timely preparation and submission of ORM and MRM data to management.