Manager-Engineering QMS-API Manufacturing-Bidar

Role & responsibilities

• Coordination with internal / External department for shut down / breakdown related jobs.
• Prepare Qualification Protocols & Reports for New Utility equipment. (URS, DQ, IQ, OQ, PQ)
• Prepare Qualification Protocols& Reports for process Equipment (DQ, IQ)
• Coordination with external agencies and contractors for vendor document.
• Coordination with purchase department and engineering store for Equipment qualification documents.
• Prepare Qualification Protocols & Reports for General Equipment (DQ, IQ) Dispensing Booth, Scrubber.
• Prepare Requalification Protocol & reports for Process, General. Utility Equipment (Agitator change, Condenser change etc)
• To Coordinate with Quality Assurance for Qualification Activity.
• Update the PM Schedule in GMP Pro all equipments.
• Maintaining the documents as per cGMP, GMP Pro.
• To Assign the ID for New Equipment (Receivers, Micron filters, Tanks) .
• Prepare Protocol & Reports for Periodic Performance Verification for critical & non-critical equipments Every Three & Five years
• Any other responsibility assigned by Manager