This Job was posted over 30 Days Ago on 07-30-2013
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- Argus Safety 7.0.x Upgrade from 5.0.
- 2+ years with validation of drug safety systems.
- 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