ClifyX ยท 1 day ago
Validation Expert with R&D systems exp
Fort Worth, TX
Contract
Hybrid
Senior Level, Lead/Staff
15+ years expClifyX is a consulting services organization in the Life Sciences industry, seeking a Validation Expert with R&D systems experience. The role involves developing validation strategies for software development lifecycle activities and ensuring compliance with internal policies and health authority regulations.
Business Information SystemsProfessional ServicesRecruitingStaffing Agency
No H1B
Hiring Manager
Vishal Swami
Responsibilities
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
Qualification
Required
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
Total Experience 15+years
Relevant Experience 15+years
Mandatory skills CSV, CSA , GXP, GAMP
Preferred
Preferable IT background to understand larger impact of architecture / technical complexities on the program
Desired skills Validation Expert for R&D systems
Company
ClifyX
ClifyX provides innovative business solutions which satisfy requirements for mission-critical reliability, scalability, interoperations.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Anil Thakur
CEO
Glenn Gilmore
Senior Managing Partner and Executive Coach
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