Validation expert

Description: We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation for R&D applications , Risk management and Quality Management.

• + yrs of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
• Understanding of key pharmaceutical compliance regulations like Computerized System Validation, CFR Part , GxP, GAMP , Data Privacy, Data Integrity and Information Security
• Develop and document the validation strategy and approach for the Software Development Lifecycle Activities (SDLC) for the global implementation of R&D systems considering GxP & Non GxP elements and recommend for risk-based testing approach as required.
• Work with Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations and provide improvement plan to streamline practices, and revise CSV related SOPs as necessary.
• Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.
• Knowledge on basic functions on R&D systems
• Knowledge of various tools/applications like JIRA, Client ALM, Qtest
• Successful track record using Lean/Agile approaches to validate assets
• Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments

Preferable IT background to understand larger impact of architecture / technical complexities on the program

Required Exp - + Years
Mandatory Skills-
CSV, CSA , GXP, GAMP
Validation Expert for R&D systems

Domain/Industry - Pharma-CSV Life Science At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity.