New job Sr. Validation Analyst // Center Valley, PA // 6+ months contract.

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Group: IT Recruiters | Technical Recruiters | Staffing Subject: Sr. Validation Analyst // Center Valley, PA // 6+ months contract. k Rajeshwar posted a job: Sr. Validation Analyst // Center Valley, PA // 6+ months contract. "Hi Friends, Hope you are doing great. This is Rajesh from NYTP. I wanted to let you know about New Job opening in Center Valley, PA. It is a 6+ months contract. Role : Sr. Validation Analyst Location : Center Valley, PA Duration : 6+ months contract. JOB DESCRIPTION: Develop, review, and approve validation documentation including CSV Risk Assessments, change control forms, requirements, validation plans, data migration plans, IQ, OQ, PQ/UAT test protocols, test cases and reports, and requirements traceability matricies. * Assist ITS staff to maintain systems in a validated state. * Develop, review, and approve SOPs and change control. * Use HPQC to review and approve test cases, results, and defects. * Review requirements and specifications in medical device environment including experience with 21 CFR Parts 11, 820, 803 and 806; understand ISO 9001 and 13485. * Provide guidance and training to ITS department on the development and execution of validation plans. * Provide expertise in review of all deliverables across the project lifecycle. * Ensure documentation meets quality standards, applicable regulatory compliance, and company guidelines. * Monitor and advise on quality of all deliverables and report to management. * Perform other related duties as assigned. Skills * A minimum of 5 years of Computer System Validation in a pharmaceutical or medical device company is required. * A minimum of 2 years of experience in validation of SAP is required. * Experience with SAP solution manager is preferred. * Experience using HPQC for testing is preferred. * Must have experience with MS Office apps including Word, Excel, Power Point and Visio. * Demonstrated analytical and organizational skills are essential. * The ability to maintain confidentiality and discretion in business relationships is necessary. * Must have expert knowledge of regulations; 21 CFR Part 11. * Must have knowledge of software lifecycle processes and methodologies with emphasis on quality assurance testing best practices. If you are available and interested in this positions. Please send me an updated resume. Please feel free to contact me for any further information. Thanks and Regards, Rajesh Kaluri New York Technology Partners - Rochester 332 Jefferson Rd Rochester, NY 14623 T: 404 380 1796 F: 201-474-8533 raj@nytpartners.com www.nytp.com"

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