I have a 12 month plus contract opportunity in Fullerton, PA. Please review the details below, if interested reply with your current word formatted resume and contact details and I will call you to discuss.
Validation Analyst
Fullerton, PA.
12 Months Plus Possible Extensions
Pay Rate: $65-70/HR (All Inclusive)
Start Date: 03/25/2013
My direct client is in need of a Sr. Validation Analyst to 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 matrices. Assist ITS staff to maintain systems in a validated state. Develop, review and approve SOP's, 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. Understanding of 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.
**Required**
•5 years of computer system validation in a pharma or medical device company
•2 years' experience in validation of SAP
•Experience with SAP solution manager preferred
•Experience using HPQC for testing.
•Experience with MS Office apps including Word, Excel, Power Point and Visio
ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES
Excellent communication (oral and written) and negotiation skills.
• Demonstrated analytical and organizational skills.
• Ability to maintain confidentiality and discretion in business relationships
• Expert knowledge of regulations; 21 CFR Part 11.
• Knowledge of software lifecycle processes and methodologies with emphasis on quality assurance testing best practices.
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