G11A Senior Executive - Quality Assurance

SUN PHARMA

0 years

0 Lacs

anklesvar gujarat india

Posted:4 weeks ago| Platform:

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Skills Required

maintenance calibration monitoring engineering flow evaluation sap technology development audit stability support report data metrics software testing service

Work Mode

On-site

Job Type

Part Time

Job Description

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 reportCleaning 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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