Validation Expert with R&D systems exp

Detailed JD (Roles and Responsibilities)

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.

• 15+ 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, 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, HP 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

Total Experience

15+years

Relevant Experience

15+years

Mandatory skills

CSV, CSA , GXP, GAMP

Desired skills

Validation Expert for R&D systems

Domain (Industry)

Pharma -CSV Life Science