G11A Senior Executive

22 hours ago

Ankleshwar, Gujarat, India SUN PHARMA Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Job description:

Computer system validation & QA-IT (Process) Related activity.

  • Review of Qualification and Re-Qualification protocol & report.

  • Review of Preventive Maintenance & Calibration records.

  • Review and approval of critical consumable items.

  • Monitoring of engineering & utility services: Current layouts of facility, building, man & material flow, HVACs, Nitrogen plant generation and distribution, purified water generation and distribution, Evaluation and reviewing of Equipment qualification.

  • Review of breakdown maintenance system.

  • SAP Activities for Engineering.

  • Handling of new product introduction at site.

  • Handling of technology transfer document.

  • Handling of development activity & review of development report.

  • Review of Scale up report.

  • Preparation of audit/readiness.

  • Activity related to Hold time study and monitoring of stability study initiation.

  • Activity related to Nitrosamine and Genotoxic impurity related report.

  • Support to Regulatory Affairs for submissions purpose.

  • Preparation and review of Cleaning validation protocol, template and report

Cleaning matrix evaluation.

  • Preparation and review of process validation protocol, template and report

  • Data compilation and submission for Preparation of Monthly/Quality metrics report

  • Review of draft master BMR in software and filled BMR related to validation.

  • Outside testing/service contract of external agency Qualification evaluation.

  • Other activities as instructed from time to time.

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