JOB RESPONSIBILITIES:

- To update equipment preventive maintenance checklist as per GMP & Audit recommendation.
- Coordination with internal department for shut down / breakdown related jobs & Breakdown report to be generated & publish.
- To ensure Initiation of procedure, planned change, change control compliance, Document change, Deviation & CAPA Closer.
- Prepare & Review the Qualification Protocols & Reports for Current Utility equipments. (URS, DQ, IQ, OQ, PQ)
- Prepare Qualification Protocols& Reports for process & General Equipment’s
- Coordination with external agencies and contractors for vendor document.
- Prepare & review Requalification Protocol & reports for Process, General & Utility Equipment’s
- To Coordinate with Quality Assurance for Qualification Activity.
- Update the PM Schedule in GMP Pro all equipment’s.
- Maintaining the documents as per cGMP related to Engineering.




- NCR Closing with respect to QMS related.
- To track breakdown hours through GMP Pro for all equipment’s and discuss preventive measures with maintenance and operation persons to minimize it.
- Maintaining the documents as per GMP Practices.
- Reviewing the training related records / data in LMS.
- To update equipment preventive maintenance checklist as per GMP & Audit recommendation.
- To impart regular safety, SGMP and Technical training to technicians and workers.
- Prepare Protocol & Reports for Periodic Performance Verification for critical & non-critical equipment’s.
- To prepare & update all equipment’s list with specification block wise.

Any other responsibility assigned by Manager

📌 Engineering-QMS-Sr Executive-Bidar
🏢 Sai Life Sciences
📍 Bidar