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Amneal Pharmaceuticals
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Senior Executive, Application Development

Senior Executive, Application Development

Amneal Pharmaceuticals

1 - 6 years

5 - 9 Lacs

ahmedabad

Posted:7 hours ago| Platform:

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Skills Required

computer system validation sap data management data security application development management risk analysis it operations sdlc scada

Work Mode

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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