23 Aug
|
Onesource Specialty Pharma
|
Bengaluru
23 Aug
Onesource Specialty Pharma
Bengaluru
Job Responsibility:
STRATEGIC:
1. Plant upgradation works planning, execution on periodical basis.
2. Plan & work towards the target set by the management based on business needs.
3. Updated & aware of cGMP requirements.
OPERATIONAL:
4. Handling DP process equipment preventive maintenance & breakdown maintenance: Integrated filling lines of cartridge, Vial & PFS with isolators, Autoclaves, packing lines, CIP, SIP skids, glass ware washers, Pass boxes, cold rooms, LAFs, HSV line, etc.
5. Coordination with HVAC team & ensure requirements in the process area is as per requirements.
6. Preparation of SOP, Preventive Maintenance schedule/planner, Documentation etc.
7. Knowledge of plant safety & cGMP requirements.
8. Coordination with user departments & plan for Preventive/Breakdown maintenance.
9. Ensure smooth operation of plant & machinery to avoid breakdowns & production loss.
10. Plan for required spare parts inventory & AMC.
11. Manpower planning & reporting.
12. To conduct Periodical energy audits to improve the efficiency of the system & to bring down the operating cost.
13. To take care of shift operations and attend to breakdowns.
14. Prepare/Review/Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ.
15. Audit & Statutory Compliance.
16. Computer skills including EMDS, SAP (PM Module), E- Val genesis system
📌 Team Lead (Bengaluru)
🏢 Onesource Specialty Pharma
📍 Bengaluru