Engineering-QMS-Sr Executive-Bidar

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.

Any other responsibility assigned by Manager