Software/Computer System Validation Engineer
We currently have a contracting opportunity in Ann Arbour, MI which can potentially go up to an year. The project have multiple positions for validation/remediating, equipment, computer system validation. I would like to check if you would be interested to pursue the opportunity for remediation project in production area. If interested, please send across your resume in word format and let me know your availability and best possible rate. Please send us a brief write up of the systems you have validated and your comfort levels in performing equipment and computer system validation/Remediation. Please find the job details below for your review: Job Details: Position: Equipment/Computerized Systems Validation Consultant Skills: Equipment/Computerized systems validation, FDA, Part 11, Traceability Location: Ann Arbor, MI Duration: 4+ Months Job Description: Participate in the validation of Equipment and Computerized Systems such as, but not limited to, Crystal Reports, Automated Equipment, Regulated Spread sheets, Medical Device Test Fixtures, and R&D Systems. Write and execute IQ/OQ/PQ validation protocols, and validation reports. Review the documentation for good documentation practices, completeness, traceability, accuracy, coverage and testability of system requirements, software defect detection, compliance risk mitigation, change management, roles and responsibilities. Enforce the company’s Quality Standards and Procedures for Equipment and Computerized Systems to maintain compliance. Vijay Vijay@neelinfo.com Ph: 408-550-2869, 415-315-9313
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