Senior Executive, Application Development

1 - 6 years

5 - 9 Lacs

Posted:7 hours ago| Platform: Naukri logo

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Work from Office

Job Type

Full Time

Job Description

Candidate should have Computer System Validation expertise in below systems:


  • Enterprise Application

  • GxP Applications Computer System Validation.

  • Laboratory Instrument software/ Control Systems.

  • Mfg. Control Systems - Mfg. Equipment / PLC/SCADA

  • SDLC

  • SAP

    • Works closely with the Security and e-Data Compliance Manager to ensure requirements for electronic data security and e-data management during any implementation or upgradation of project.

    • Implement & maintain the IT CSV Policies and IT Security policies to ensure IT Operations.

    • Knowledge of 21 CFR Part 11 & EU annex 11 requirements.

    • Regulatory Audits - To closely work with Quality team for providing the required technical expertise support for various regulatory audits.

    • Knowledge of QMS , Change Control Management, Deviation, CAPA.




  • Preparation and review of Validation (Strategy) Plans, User Requirement Specifications.

  • Preparation and Review of Functional Specifications S/W Design Specifications or Configuration Documents.

  • Preparation of computer system validation documents.

  • Traceability Matrix, Risk Analysis.

  • Validation Reports, Change Controls/Deviations etc.

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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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