G11A Senior Executive
3 days ago
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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