Sentences with phrase «computer system validation»

Project Manager and Product Manager with a broad background, over 20 years of experience in all phases of SDLC including the areas of Application Development, Implementation, Deployment, Project Management, Process Improvement, Computer System Validation and other positions of increasing technical responsibility.

AREAS OF EXPERTISE: * Over 12 years of experience in Computer System Validation (CSV) / Quality Assurance in the Pharmaceutical and Biotech industries including specialization in 21 CFR Part 11 Compliance.

* Experience in Computer System Validation including Compliance Assessments, Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), Validation proto...

Developed and implemented computer system validation templates for new system development based on in - house SOPs and pharmaceutical industry guidelines.

Not exact matches

Cohen, whose background includes developing operating systems support for computer games, has developed a program called LEVER - short for Lineage Editing and Validation program - that can identify, tag and track live cells, capturing patterns of motion and cell division, using sequences of microscopic time - lapse images.

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Reviewing CSV deliverables Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Reports, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and Validation Summary Reports for Data Integrity compliance.

Tags for this Online Resume: Desktop Computer, Research and Development, Training, Benefits, Debugging, Systems Analyst, Troubleshooting, Intranet, Data Analysis, Data Migration, SOPs, Technicl Writing, Validation

An entrepreneur and small business owner, Carrie has experience in photography, computer programming, nursing and Validation Therapy with dementia patients, DNA testing in contract with the Attorney General's Office to establish paternity, the court and prison systems, and mediation.