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CSV Validation Engineer

Cleanstep Pharma And Engineering Solutions

2 - 7 years

3 - 8 Lacs

Hyderabad Pune Mumbai (All Areas)

Posted:2 months ago| Platform:

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Skills Required

GAMP5 LIMS Risk Assessment V-model Performance Qualification IT Compliance Operational Qualification Computer System Validation SDLC PLC Validation CSV Validation Documentation Skills 21 CFR Installation Qualification Validation plan HPLC EU Annexure 11

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report

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CSV Validation Engineer