Title:  G11B - Senior Executive - Quality Assurance

- 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.