CSV Lead

Job Title

Experience - Validating ERP to AWS Data migration process and Validating Data migration project

• Experience in the Pharmaceutical, biotechnology, or medical device industry
  ¿ 5+ years' experience with System Development Lifecyle¿
• 5+ years' experience in Computer System Validation (Based on the role selected)¿
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.¿
• 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.