IC | Validation expert

Computerized System Validation Specialist

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. Fifteen plus years 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, 21 CFR Part 11, GxP, GAMP 5, 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.