CSV Lead

Job Title: CSV Lead

Location: Raritan NJ Onsite

Duration / Term: 6 months Contract

Job Description:

• 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 guidances 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.

Key Skills:

CSV AWS Data migration UAT GAMP Pharmaceutical