AddressHead - Engineering [DGM]
- Handling Maintenance activities for Utilities, Plant Equipment's for OSD , Electrical Maintenance, Instrumentation , calibration, HVAC Civil and designing , manpower & monitoring overall Site Engineering operations exposure to Large Volume block.
- Managing Team of 40- 50 People across various Managing the Technical bid analysis, preparing budgets & mechanical specification in comparative of equipment's required including electrical; instrumentation; reviewing of P & ID Drawings.
- Proactively identifying areas of breakdowns & take steps to avoid the recurrence as well as maintain root cause analysis reports.
- Support QMS team for Deviation investigation, Change control and CAPA implementations.
- Handle all Equipment , HVAC, Utility Qualification/Validation and requalification.
- Overseeing strict adherence to cGMP, and USFDA for handling safety & environment.
- Conducting the activities related to preparing Material & Energy Balances, Conceptual Layouts overseeing system audit.
- Charting several safety measures for minimizing occurrence of safety incidents and maintaining conceptual documents through monthly safety meeting
- Responsible for the breakdowns, Preventive maintenance as per schedule and Necessary technical modifications in equipment's of Utility, Packing & process equipment's.
- Responsible for Monthly report related to plant efficiency and breakdown analysis.
- Responsible for Different cGMP audits /Compliance like USFDA.
- Responsible for CSV as per GAMP 5.
Candidate Profile:
1. The candidate should be from Pharma Industry only, having exposure to Oral Solid Facility.
2. The candidate should have handled engineering and maintenance activity for Large Volume block.
3. The Candidate should have Exposure to USFDA regulatory Audits.
4. The Candidate should have worked on Digital Initiatives like MES.
5. Its a team handling role and the candidate should have handled team of 40- 50 people across departments of engineering and maintenance.
