Employment Type: Full-Time
: Responsible for designing and leading the validation and compliance activities for GxP computerized systems per regulatory requirements. Manage the validation efforts of small to large sized projects. Perform GxP assessment/Risk assessment of computerized systems to assess their impact on the patient safety, product quality/efficacy, data integrity. Perform 21 CFR Part 11 (FDA) and Annex 11 (EMA) assessment of computer systems to ensure compliance to FDA and European regulatory agencies. Develop or, review and approve computer system validation deliverables for GxP applications, including but not limited to: Validation Plan, Requirements Specifications (URS/FRS), Qualification protocols, Validation Summary Reports. Execute or, review and approve the approved qualification protocols in a controlled environment and document the test results. Document, analyze (root cause) and track deviations, Exception Reports (ER), Corrective Action Preventive Action (CAPA). Author or, review and approve change requests, Standard Operating Procedures (SOP). Perform periodic review of Computer Systems and their Audit Trail.Required Masters or foreign equivalent in CS, Technology, CIS, MIS, Engineering (Any), or any related field. Requires 2 years of experience in the job offered, Validation Engineer, Software Engineer, Consultant, Programmer Analyst, Testing Analyst, or related. Must be able to travel/relocate to various client sites throughout the U.S.To apply please send resumes to HR, Infotech Spectrum, Inc., 2060 Walsh Avenue, Suite 120, Santa Clara, CA 95050 or email resumes to email@example.com Apply to this Position!InfoTech Spectrum IncInfotech Spectrum Inc. All Rights Reserved.
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