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Senior Officer, Application Development at Amneal India
Sarkhej, gujarat, India -
Full Time

Start Date

Immediate

Expiry Date

15 May, 26

Salary

0.0

Posted On

14 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Computer System Validation, GxP Applications, Laboratory Instrument Software, Control Systems, Manufacturing Control Systems, PLC, SCADA, SDLC, SAP, Electronic Data Security, E-Data Management, 21 CFR Part 11, EU Annex 11, Regulatory Audits, QMS, Change Control Management

Industry

Pharmaceutical Manufacturing

Description
andidate 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 Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Responsibilities
The role involves implementing and maintaining IT CSV and Security Policies, ensuring compliance during system implementations or upgrades, and providing technical expertise during regulatory audits. Responsibilities include preparing and reviewing various validation and specification documents such as Validation Plans, URS, and Traceability Matrices.