Computer System Validation

Job Responsibilities:

• Computerized System Validation (CSV) Analyst Job Profile:
• Understand clients CSV, Quality and Risk management strategy, define and align with the processes and procedures for the program/project
• Assist in providing strategic inputs for CSV projects
• Should have knowledge of GxP system, GAMP, 21 CFR Part11 software validation
• Should be able to gather requirements (user/functional) clearly from multiple stakeholders
• Able to prepare CSV life cycle documents /qualification related protocols (like URS, FRS, FRA, DS/CS, IQ, OQ, PQ, RTM).
• Support in preparing test scripts annexures.
• Able to execute/ support in executing test scripts and recording results.
• Able to handle the projects independently

 Requirements

• Documentation management/generation in a Content Management System a plus
• Working knowledge of statistical methods.
• Working knowledge of global regulated markets (FDA, CLIA, CAP, CFDA, etc).
• Experience with html and /or xml a plus
• 4+ years of experience in validation of computerized systems in pharmaceutical products or manufacturing environment.
• Must have experience developing, reviewing and execution of CSV Protocols.
• Technical Writing Skills.
• Must have experience developing, reviewing and execution of CSV Protocols
• Knowledge on computerized systems with data collection software (database). 
• GAMP5 methodology for validation and cGMPs regulations.
• Great skills writing general documentation in English and using MS Office applications.
• Great communication skill with all levels of the organization.
• Available to work non-standard shift is require.

 Behavioral Competencies:

• Task-oriented and goal-driven - focused on outcomes.
• Great team player
• Creative with problem solving mindset.
• Open to receiving objective criticism and improving upon it.