Engineering-QMS-Sr Executive-Bidar

SAI Life Sciences

Bidar District

On-site

INR 400,000 - 500,000

Full time

7 days ago

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Job summary

SAI Life Sciences is seeking a maintenance engineer to oversee preventive maintenance of equipment in alignment with GMP and audit recommendations. The role involves coordinating shutdowns, generating breakdown reports, initiating change controls, and preparing qualification protocols for new and existing equipment.

You will collaborate with QA for qualification activities, update PM schedules in GMP Pro, and maintain cGMP documentation.

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 New 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.

Job description

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 New 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.