Job Description: Pay Range: $60hr - $65hr Skills:
- Computer System Validation.
- Validating ERP to AWS Data migration process.
- 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 Technology Quality management.