CSV Consultant

Educational Requirements Service Line Responsibilities

• 5+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
• Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQs, TRM.
• Assure compliance with GxP (GMP, GCP, GLP) privacy requirements. Develops and maintains IT GxP compliance documentation.
• Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.
• Stakeholder management and good executor with required communication.
• Candidate must have fair conceptual understanding on below key areas: IT QM, Validation/Qualification, Risk management, Handling of defects/Deviations, Investigations, CAPA Handling, Test Management Compliance.
• Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.
• Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc.

Additional Responsibilities

• Ability to develop value-creating strategies and models that enable clients to innovate, drive growth and increase their business profitability
• Good knowledge on software configuration management systems
• Awareness of latest technologies and Industry trends
• Logical thinking and problem solving skills along with an ability to collaborate
• Understanding of the financial processes for various types of projects and the various pricing models available
• Ability to assess the current processes, identify improvement areas and suggest the technology solutions
• One or two industry domain knowledge
• Client Interfacing skills
• Project and Team management

Technical and Professional Requirements Preferred Skills

• Domain->LifeSciences->Pharma Regulations->Computer Systems Validation (CSV)