Job Details

ID #45868098
State District of Columbia
City Washington
Job type Contract
Salary USD $DOE DOE
Source ThoughtStorm LLC
Showed 2022-09-21
Date 2022-09-21
Deadline 2022-11-19
Category Et cetera
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Computer System Validation- Local to VA

District of Columbia, Washington, 20003 Washington USA

Vacancy expired!

UPDATED NOTES: Local candidate no relocation , hybrid 3 days a week for a very strong cand can do once a week Please let me know who we have ASAP this HM will move Address: 45472 Holiday Drive, Suite 7, Sterling, Virginia 20166, US Position: CSV Analyst Location: hybrid

  • If hybrid, how many days/week in office and are there specific days of the week required to be onsite? 3 days in office per week
Duration: 6 month C2H Interview Process/# of Rounds: above Top skills:
  • Computer system validation experience
  • Biotech/pharma/medical device/healthcare industry experience
  • Audit experience with regulators (e.g. FDA, etc. )
  • Description: The CSV analyst role is to develop, establish, and enforce Computer system validation standards and measures for the information technology services within Eureka and it s subsidiaries. Overseeing the overall CSV process outputs, this individual will support CSV efforts within business cases, proposed projects, and systems requirements over the course of software development, or software acquisition lifecycles. The CSV Analyst will apply proven analytical and problem-solving skills to help validate technology processes through careful testing in order to maximize the benefit of business investments in IT initiatives. Responsibilities and Duties Develop and/or review/approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, User Acceptance Tests (UAT), Design Qualification (DQ), IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Provide CSV oversight of all GxP computerized system validation activities: conduct/lead GxP assessments, risk assessments, part 11 assessments. Work closely and collaboratively with various business units including, Operations, Engineering, Customer service, regulatory and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Coordinate validation/qualification activities, propose and implement validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Lead/participate in supplier site Validation Assessments/Audits and work with suppliers to troubleshoot and improve systems and processes. Generate System Assessment/Audit Reports and follow-up with suppliers on implementation and closure of observations/recommendations identified in the report. Generate or review/update computer system related policies, procedures, templates, forms, etc., as needed to improve/evolve the validation program and implement them. Work with Management on system validation planning (both short term and long term) supporting diagnosis of validation problems (both internal and external), implementing corrective and preventive actions to resolve those problems, and support continuous improvement of validation programs. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP s regulations, GAMP, ISO, industry standards, policies and procedures.
    • Other duties as assigned.
    Qualifications and Skills University degree in the field of continuous improvement, computer science or information systems and 4 years related professional work experience. Master s degree in any of these fields or Master of Business Administration with technology as a core component preferred with 2 years of additional experience. 5 years direct experience in contributing to the design, development, and implementation of quality assurance standards for software testing. Strong knowledge of system testing metrics, best practices and methodologies. Direct hands-on experience with ad hoc query programs, automated testing tools, and reporting software. Proven data analysis, data verification, and problem-solving abilities. Experience with statistical reporting and analysis. Good project management skills and/or substantial exposure to project-based work structures. A fast learner, detail oriented, decisive, and enjoys a fast-paced work environment Ideal candidate must like change. This position will drive process maturity, standardization, and help champion continuous improvement Open for relocation.

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