At least one year of hands -on experience with Argus 7 highly desirable.
Experience with data migration validation/testing.
Minimum of 5 to 6 years experience in Quality and Compliance with substantial hands-on computer system validation experience.
Prior experience leading/mentoring other validation professionals
Prior experience working with offshore teams.
Experience in FDA regulated environment with good understanding of GxP related processes including Risk Based validation.
Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols,
Test Summary reports and Compliance/validation reports.
Experience in Software Development Lifecycle (SDLC).
Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
Experience with in Change Control processes.
Experience with various FDA regulations (e.g. 21 CFR Part 11, 210, 211, 820)
Experience is creation of SOPs.
Knowledge of FDA guidance’s and industry standards (i.e., GAMP).
Hands- on experience in HP Quality Center and QTP.
Strong verbal and written communication skills.
Perform assessments of computer systems and processes at client sites (compliance with internal procedures, industry best practices, and regulatory requirements)
Develop validation strategy documents, write user requirements, SOPs, IQ/OQ/PQ, and create validation summary reports
