*Hello,*
*Kindly let me know if you have anyone available for the below position.* *Please share resume at **[email protected] <[email protected]>* *Hi,* *Please submit consultants with their birthday (day and month) and the last 4 digits of their SSN.* *Position: CSV Lead Analyst * *Location: Malvern, PA * *Duration: 1 Year * *Interview: Phone than Skype * **Past job titles/experience that a desired candidate would have: Project manager or Lead Validation Analyst, Testing Engineer, *Summary of Position* Project Manager/Validation Lead Analyst supports manage the project plans for the UDI IT workstreams and the computer system validation process. This individual will also lead the system validation efforts, with development of validation strategies, test scripts, execution of testing and review and report out of testing results and completion of validation deliverables - Responsible for project integration management through the PM methodology phases; discovery, planning, execution, deployment, and close - Manages and documents project scope and scope changes to meet objectives, budget, and timelines Coordinates project activities status reporting/communications, meeting minutes, decisions/action item, risks and issues, budget plans to actuals - Works with the project teams to develop validation strategies for projects and works closely with project managers and program managers to meet the deadlines. - Leads the technical and business team members to ensure compliance with system requirements, corporate quality standards, HIPAA guidelines and FDA regulations (21 CFR part 11) - Oversees overall document management for all validation deliverables including routing and approval process of documents. - Generates/revises Validation Master Plans (VMP), Qualification Protocols (IQ/OQ/PQ), Trace Matrices (RTM), Test Plans, Risk Assessments (RA), and Final Summary Reports (VSR) - Coordinates the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage and test strategies. - Review requirements and design documents and verification documents for compliance requirements Works in parallel with the business SMEs and IS Applications staff to create thorough, accurate and comprehensive test scripts. - Develops, maintains and executes validation test scripts, test metrics and generates reports for management use in determining project and applications test status and coordinates testing schedule with IS/IT team. - Performs post-execution review of test cases for completeness, accuracy, and adherence to policies and procedures. *Key Requirements* · Project Management experience in managing scope, cost, schedule, quality and risk is required · Experience in the Medical Device / FDA regulated industry with thorough knowledge of quality management and CSV (GMP, 21CFR Part 11, GAMP) aspects of computer system application and demonstrated profiency in computer system validation(CSV) · Experience in working validation of ERP, PLM, Labeling COTS applications. · Demonstrates attention to detail and organizational skills · Strong technical writing, verbal communication, interpersonal and problem solving skills · Must demonstrate a high commitment to quality · Must be able to manage multiple tasks and work independently · 8 Minimum years of experience required · Bachelor’s degree: Bachelor of Science in IT, Chemistry, Pharmacy, Biology, or related science or technical field preferred · Specific hardware/software experience required: Knowledge/experience of Quality Management Systems( Document Control), PLM, Labeling, preferred , ERP desirable . i.e. Trackwise, WIndchill, Documentum, MasterControl · PMP Desired not required · Top 3 qualifications in a candidate o • Computer System Validation Lead – responsible for leading and managing computer system validation including: creation of Validation Master Plans (VMP), Qualification Protocols (IQ/OQ/PQ), Trace Matrices (RTM), Test Plans, Risk Assessments (RA) documentation, coordination and execution of validation testing and testing results reporting . o • Project Manager – responsible for coordinating project activities status reporting/communications, meeting minutes, decisions/action item, risks and issues, budget tracking, creation and or review of requirement project management documentation. o • Experience in the Medical Device / FDA regulated industry with thorough knowledge of quality management and CSV (GMP, 21CFR Part 11, GAMP) aspects of computer system application and demonstrated profiency in computer system validation(CSV) Thanks and Regards *Neetu Narwal* Technical Recuriter * IDC Technologies Inc.* • 1851 McCarthy Boulevard, Suite 116, Milpitas, CA, USA, 95035 * Phone*: 408-457-9381 • *Ext.*: 4032 • *Fax*: 408-608-6088 • *Email*: [email protected] *Gtalk: *[email protected] CMM Level 3 Company • ISO Certified • BBB Accredited Business • 16th Best Company (2013) in Silicon Valley *NOTE: This mail has been sent through Google Groups. 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