Senior Executive – Production QMS | Zydus Hospira | Ahmedabad

Job Description

Injectable Experience is mandatory

  • Knowledge of the QAMS System
  • Preparation & review of MPCRs and eBMR
  • Preparation & review of the SOP, Risk assessment, and Protocol (e.g. URS/DQ) of various equipment, facility, and utilities.
  • Prepare, and review the audit report as per regulatory requirements.
  • Handling of Change Control, Deviation, and Incident.
  • Root cause analysis and effectiveness of Corrective & Preventive action for Compliance and implementation after recommendations.
  • Preparation of Investigation and impact assessment.
  • Preparation and review of investigation report generated by deviation.
  • Coordinate with other departments to close the corrective & preventive ( CAPA) events against audit Compliance.
  • Ensure cGMP & GDP compliance in routine activities per the current regulatory guidance.

Training to be provided to approve Protocol & SOP to all concerned department personnel

Location