Executive - Pharmaceutical Production

1. Review & ensure complete maintenance of utility system (i.e. Water system, Steam Compressed air, Boiler, HVAC, chiller etc.)
2. Preparation and review heat load, peak load calculation for all the utility system as per operational requirements.
3. To coordinate and execute the projects, making detailed plans to accomplish goals.
4. Shall review the EMS/BMS reports.
5. Shall co-ordinate with vendor to solve the problem / discrepancy on priority basis.
6. Shall involve and support to equipment, facility, utility & process qualification.
7. Shall be responsible to maintained overall CGMP in all operation within the Utilities.
8. Shall be responsible for engineering QMS notification initiation and closure, following the below principles:
9. Design error detection and prevention by using root cause analysis (specifically the "5 Whys") to identify and eliminate recurring sources of defects.
10. Routine primary maintenance like Cleaning, Lubricating and Inspection, Tightening and Adjustments (CLITA),
11. Review of validation/qualification protocols / reports.
12. Ensure 100% Inventory of consumables / spare parts.
13. Ensure compliance with Good Manufacturing Practices (GMP and ISO), safety policies, and good housekeeping and that safety and hazard practices are understood and implemented.
14. To analyse and solve engineering-related problems with effective manner.
15. To work on lean management techniques to improve performance of equipment.
16. Preparation / or review the engineering Operational related SOP’s.
17. Review and raising the change controls for major and critical changes related to facility modifications, qualifications, and SOP revisions and timely closure of CAPAs.
18. Attending daily investigation review meetings with Cross Functional Team (CFT) and site investigation team as and when required.
19. Preparation of equipment qualification documents.
    Preparation of miscellaneous study protocols for engineering related activities.
20. Having in depth and thorough knowledge on Operations, maintenance and qualifications of Purified Water Generation and Distribution System, Multi Column Distillation plant, WFI Distribution system, Pure Steam Generation, and related online documentation in logbook as per GMPs.
21. Preparation of Breakdown assessments and impact assessments which nullifies the impact of incidents observed.

Graduate in Engineering (Mechanical/ Electrical/ Instrumentation)