Job Title: Validation expert
Work Location : Fort Worth, TX (Onsite)
Contract duration: 12+ months Contract
Job Description
Must Have Skills
CSV, CSA , GXP, GAMP
Desired skills
Validation Expert for R&D systems
Domain (Industry)
Pharma -CSV Life Science
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
Never miss an opportunity! Create an alert based on the job you applied for.
