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