Senior CSV Consultant (CFR/Gamp5/Quality Mang. System)
We are currently looking for a Sr. Computer Software Validation Lead with a strong background in Quality Systems Compliance, Risk Assessments, Qualification Testing, Planning, and Training Please email your Resume for review Project Lead Responsibilities: This is a highly visible position that provides leadership on validation plans, test development and processes, documenting validation test results and overseeing validation test procedures. Efficiency, accuracy, team support and excellent verbal and written communication skills are essential to success in this position. Ideal candidate would come for a Quality Systems Compliance Validation/UAT background in a non-R&D/NPI environment. Duties include: Reviews Project documents to determine if Project requires an application/tool to be validated. Writes Quality Plans including: Validation approach, Regulatory Risk Assessment; Quality System Controls within the project (Doc Control, Record Controls, Training, etc) Reviews User Requirements: Assess testability of requirements ,Ensure any Part 11 Requirements for Electronic Records/Electronic Signature are included Participates in Blueprint and Development Phases : Obtain understanding of the business process; Obtain understanding of how the tool will implement the process understand the methods used to implement (Custom Code vs Out of the Box functionality) Creates User Test Plan based on processes and tool selection and participates in Risk Assessment Develops Detailed Test Scripts with Expected results based on: How the tool automates the process, including negative testing ; Complexity of the implementation (eg custom code vs out of the box functionality) Creates and Documents Detailed Test Script with Requirements traceability Executes test scripts prior to UAT/Planning UAT Sessions/Create any needed UAT specific training (process/tool training), and writing validation reports. Manages the event management process during UAT testing. Writing deviations that occur during qualification. Reviews executed test protocols, reports and deviations for application testing for compliance with quality and regulatory requirements. Conducts validation document peer review. Provides guidance to protocol testers and leads UAT planning and coordination to business program managers to support validation of computer software applications. Skill Set Expert knowledge of and experience executing Quality System software validation requirements, methods, and standard Awareness of US FDA Part 11 Electronic Record/Signature requirements Ability to provide clear and concise documentation activities, most specifically the design and documentation of user acceptance scripts, execution of scripts, and record-keeping Efficiency, accuracy and excellent communication skills are essential to success in this position. 6-8 years working with IT/IS personnel with 3-4 years of direct experience in FDA-regulated environment. This includes a thorough understanding of and experience with the following: Validation and Infrastructure Qualification GxP regulations (GMP, GCP, GLP) and 21 CFR Part 11, 21 CFR 820 GAMP5 Quality management systems meeting the requirements of ISO 20000 or ISO 9001 Strong communications skills (verbal and written) Ability to build positive working relationships within the organization Strong history of Customer service (application stakeholders) and ability to influence and engage at various audience levels based on subject matter Ability to successfully manage concurrent tasks from multiple business program managers Ability to plan, organize, and control work activities Is results driven Able to work independently and in a team environment Have Document and Records Management Experience Have Change Control Experience Have Change Management Experience Overtime : straight time
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