CSV Validation Engineer

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