Title:  Engineering - Manager - 1

1. To ensure 100% Maintenance of all Plant Machinery process Equipment’s (Granulation equipment’s-FBD, FBE, RMG, Blender, Tablet compression machine, Tablet Coating machines, Blistering machine, Cartonating machines, Packing Bottle machines, Inspection machine etc.) & its relevant. Ensure minimum time for the breakdown to be achieved

2. To ensure technician & staff deputed at breakdown, preventive & building maintenance works accordingly as per approved shift schedule.

3. To ensure the timely completion of the work orders, purchase orders & purchase requisition & ensure the work measurements are proper and timely bill booking & approval from the Block Head.

4. To involve & support in the modification/ongoing CAPEX as well as projects works for the right implementation of the equipment to ensure right & easy maintenance of the same in future.

5. To ensure the services vendor at site & loading/unloading, fabrication & civil works are carried out as per the GMP norms with safety norms also. AMC if any should be inline as per schedule.

6. To train the people & people management & ensure all have to trained in LMS system as well as applicable OJT in place as per the requirements.

7. To ensure Preventive maintenance & Breakdown maintenance program through SAP system. All records & schedule should be traceable as per SOP.

8. To handle all the stakeholders for their works & timely maintenance solution to each with defined timeline.

9. To coordinate with EHS Department for statuary complies & ensure the safety maintenance.

10. To ensure the critical spares/inventory/hardware’s to be available for the maintenance purpose. 24x7 shift management & availability of the manpower’s for the maintenance & rectification works.

11. Implementation of Good Engineering Practices, Good Manufacturing Practices, Data integrity and Good Documentation Practices should be followed & no any noncompliance.

12. To Co-ordinate the internal engineering cross function section like utility, calibration & water system for getting the rectification & timely works completion relevant to process equipment/APU. 

13. To prepare the investigation, root cause identification and derive CAPA in case of incident of system failures/out of specification observation and request change control, action item through Track wise (QMS) system.

14. Handling of EDMS, LMS, track wise accordingly & input to be done for the smooth system handling & documents handling accordingly.

15. Co-ordinate for the self-inspection/visit/audit at site & ensure proper walkout for the same while inside the premises/ process equipment area.

16. To handle observations & ensure timely compliances of observations/points same within timeline.

17. To handle the vendor/OEM as per requirements & ensure the GMP compliances accordingly.

18. To ensure all required drawings/layouts of AUTO CAD generated & approved.  Status label, record shall be in place & current updated version of the SOP. Drawings/layouts regarding plant equipment & APU system