Engineering-QMS-Exe/Sr Exe-Bidar

SAI Life Sciences; Bidar District; On-site; INR 600,000 - 900,000; Full time

Job summary

SAI Life Sciences in Karnataka is seeking a Maintenance Engineer focused on GMP-compliant equipment upkeep. You will update preventive maintenance checklists, coordinate shutdowns, and ensure proper change control and CAPA closure.

Responsibilities include preparing qualification protocols (URS, DQ, IQ, OQ, PQ) for new utilities and equipment, maintaining cGMP documents, tracking breakdown hours, and imparting safety and technical training to technicians.

Responsibilities

• Update equipment preventive maintenance checklist as per GMP and audit recommendations.
• Coordinate shutdown/breakdown related jobs with internal departments and publish breakdown reports.
• Ensure initiation of procedures, planned changes, change control, documentation changes, deviation & CAPA closure.
• Prepare and review Qualification Protocols & Reports for new utility equipment (URS, DQ, IQ, OQ, PQ).
• Prepare Qualification Protocols & Reports for process & general equipment.
• Coordinate with external agencies and contractors for vendor documentation.
• Prepare & review Requalification Protocol & reports for Process, General & Utility Equipment.
• Coordinate with Quality Assurance for Qualification Activity.
• Update the PM Schedule in GMP Pro for all equipment.
• Maintain documents as per cGMP related to Engineering.
• NCR Closing with respect to QMS related.
• Track breakdown hours through GMP Pro for all equipment and discuss preventive measures with maintenance and operation personnel to minimize it.
• Maintain the documents as per GMP Practices.
• Review training related records/data in LMS.
• Impart regular safety, SGMP and technical training to technicians and workers.
• Prepare Protocol & Reports for Periodic Performance Verification for critical & non-critical equipment.
• Prepare & update all equipment lists with specification block wise.
• Any other responsibility assigned by Manager.

Job description

Role & 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.
• Any other responsibility assigned by Manager.