What are the responsibilities and job description for the CSV Lead (Onsite/Hybrid) position at W3Global?
Job Details
Must Skills: Domain Competencies (APPS)-Pharma Validation & Verification-Computer System Validation (CSV)
Description:
New Billing, Exclusive, Committed Computer System Validation
Validating systems used in R&D/Clinical and PLM pillars Validating Data migration project.
Experience in the Pharmaceutical, industry 8 years experience with System Development Lifecyle
Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation in Clinical Space
Knowledge of FDA guidance s and industry standards (i.e., GAMP)
Experience in writing and executing documentation for all aspects of the validation deliverables like Requirements, Compliance/validation
Plans, test protocols, Test Summary reports and Compliance/Validation Reports
Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
Strong verbal and written communication skills.
Ability to work as a team player, lead a team or accomplish tasks without supervision.
Ability to work with remote teams and support several changes/projects simultaneously.
Ability to provide Validation guidance, timely reviews, and escalations to Techolongy Quality management.
