Please send the resume with rate and contact details to resu...@gallopresources.com
Roll: Senior Business Systems Analyst/Validation Lead Location: South San Francisco - CA Duration:6 Months Only:US Citizens&GC-(Who can work on W2) Job description, Need from Pharma background with experience in GCP & GMP and all Job Title: Senior Business Systems Analyst/Validation Lead Job Description: · This contractor will fill in a systems analyst/solution lifecycle manager for projects within the Product Development Informatics group supporting Global Product Development Clinical Operations, Biometrics and Clinical Sciences business functions. This role includes working on major cross-functional system initiatives. · He/she will analyze the customer needs, assess risks, perform impact analysis, define solutions, document requirements and functional specifications, work with the development team, develop validation and testing strategies and plans and validation/test summary reports. · He/she will participate in the review of system change requests and enhancements. · He/she will be asked to help in creating project plans with regards to planning tasks and timelines related to his/her job assignment. Job Duties: · Contribute to the development of new solutions / projects and solution enhancements, provide subject matter expertise into detailed solution design, and work with the development teams in the creation of solutions to meet defined requirements · Act as Business Systems Analyst on major projects/programs and may function in an analytical or design leadership role ensuring successful completion and delivery · Author and/or review documentation throughout the project life-cycle, and contribute to test planning, test execution and testing documentation · Work directly with customer groups and proactively communicate across global project work-streams and vertical teams, and take responsibility for fostering and improving teamwork · Demonstrate and apply extensive understanding and application of tools, principles, concepts, and techniques related to requirements definition, data flow, usability and process analysis. · Contribute to management and support of solutions in their operational status, coordinate activities related to changes for GxP systems, provide content knowledge to the incident, problem and change management processes · Perform 2nd and 3rd level support and system administration activities not managed by the Infrastructure or Development Centre services and ensure system documentation is kept up-to-date in compliance with the validation requirements of the solution Skills: · Strong user requirements, system analysis and technical skills, as well as proven skills in documentation authoring · Must have experience developing risk-based system assessment, impact analysis, validation plans · Experienced creating and/or reviewing installation qualification, operational qualification and performance test documentation · Ability to support prototyping activities that will validate business requirements and solution definition · Experienced working in a project-driven environment. Project experience on a regional/global scale is a plus · Excellent communication skills (written and verbal in English, other languages are plus) · A self-starter who needs minor supervision · Ability to recognize and react to situations with a sense of urgency and problem ownership/accountability, with a focus on customer service Education: · Bachelor’s degree in Computer Science, Informatics, Life Sciences or a related discipline · A minimum of five years work experience as an IT business analyst, systems analyst combined with software validation/quality assurance experience with knowledge of pharmaceutical industry and processes · A good understanding of the principles of software validation in regulated industries is a plus, including 21 CFR Part 11, PDA 18, related FDA guidelines and regulations, as well as ICH GCP guidelines. · Knowledge of clinical trial management systems (CTMS), clinical trial portals (CTP), Electronic Data Capture (EDC) systems, document management systems such as Livelink, Microsoft Sharepoint, SAS, R-Software, Secure Data Exchange a plus Regards, GALLOP Resources, Inc 1220 N Market Street, Suite 806, Wilmington, Delaware, 19801 www.gallopresources.com -- You received this message because you are subscribed to the Google Groups "IT Auditor Resumes" group. To unsubscribe from this group and stop receiving emails from it, send an email to itresumes+unsubscr...@googlegroups.com. To post to this group, send email to itresu...@googlegroups.com. Visit this group at http://groups.google.com/group/itresumes?hl=en. For more options, visit https://groups.google.com/groups/opt_out.
