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Sr. Validation/SQA Engineer

Company: LS Solutions, Inc.
Location: Crystal Lake
Posted on: November 18, 2020

Job Description:

LS Solutions is working with a leading pharmaceutical company who needs additional bandwidth in their IT QA and Validation team. We are looking for an IT QA resource to support their GMP, GDP and GVP systems. This position will be responsible for working closely with the operational functions and other QA groups to provide oversight of GxP computerized system implementation, maintenance, and retirement. This role will review and approve computerized system lifecycle documentation as well as provide GAMP, Part 11 Annex 11, and quality assurance expertise to key stakeholders. Strong experience using automated testing (and the platform currently being used will be GitHub so highly prefer this experience but any other automated testing experience will be considered) Life Sciences client experience is required (i.e. Pharma, Biotech, Medical Devices etc) Key Responsibilities Develops understanding of regulations pertaining to the implementation and use of computerized systems. Participates in system implementationchanges with project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk based approach based on GAMP 5 Reviews and approves system lifecycle deliverables for new and modifications to existing computerized validation systems Review of Artifacts, Provides SQA expertise, Consults with other Quality team members and relevant internal stakeholders to identify define high risk areas with the intent on focusing on patient safety, product quality and data integrity Identifies and escalates areas of risk or non-compliance to manager leadership team Participates in performing Periodic Review activities of Computerized Systems Provide support to regulatory inspection preparedness activities as needed Critical Success Factors include experience with the following Performing Quality Assurance function related to Computerized Systems Infrastructure Proficiency with regulations related to FDA regulations Use of computerized quality management systems Experience with Computer System Validation, Quality Assurance (Automation) Quality metrics, dashboards, analysis and improvement programs Knowledge of GAMP and Agile validation lifecycle and methodologies

Keywords: LS Solutions, Inc., Crystal Lake , Sr. Validation/SQA Engineer, Other , Crystal Lake, Illinois

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