Validation Lead

Company: Dynamic Systems Resources
Location: Chicago
Posted on: January 27, 2023

Job Description:

Summary & Key Responsibilities:
Develop system development life cycle documents related to global ERP system.This includes system specification documents, validation plans and testprotocols, and procedures. Work with regional project teams to ensure globalvalidation strategy is understood and followed. Develop development programmingstandards as needed.1. Act as Validation Lead as assigned for Global US Implementation or Regionfor Global ERP.
2. Generate Validation Plan, Infrastructure Master Plan, Qualification Protocols,Test Plans, Risk Assessments, Reports, Trace Matrix, as needed.
3. Participate in and guide team in generating User Requirements, Functionaland Design Specifications. Provide guidance in generation of hardware systemspecifications.
4. Gain understanding and follow defined SDLC. Ensure quality validationprocesses are executed as defined by procedures.
5. Using risk-based approach to validation, determine testing, documentationand verification activities, with appropriate justification of the approach.
6. With team, develop validation strategy for components/workstreams thatcomprise the ERP system. Deploy strategy, defining documentation requirementsand hierarchy for integrated system.
7. Manage electronic routing of required documentation*ensuring complianceto current procedure for e-approval.
8. Communicate status, solutions and concerns. Disseminate information ina timely manner within the team. Facilitate and address issues within project.
9. Manage validation team*coordinating documentation and testing. Generatetest scripts, as needed. Execute testing as required.
10. Collaborate with business, quality, and technical individuals throughoutproject in generation of project / validation required deliverables.
11. Prepare validation package for archival.
12. Develop SDLC documents for global ERP system
13. Proficient in the various testing phases such as Manual Testing, GUITesting, Functionality Testing, Security Testing, System Testing, RegressionTesting, Integration Testing, Performance/Stress Testing, User AcceptanceTesting, Back End Testing
14. Knowledge of testing tools like TestDirector, WinRunner, LoadRunner,Rational RequisitePro, Rational TestManager, Rational Robot, Rational ClearQuest,RUP, Rational SoDA for Word, SilkTest

Job Requirements:
1. Minimum BA / BS or relevant work experience in information systems, engineering,science or business.
2. Highly skilled in Computerized System testing and validation in the healthcareindustry. At least 5-7 years validation experience in both infrastructurequalification and application validation.
3. Proven results in managing validation aspect of software / infrastructureproject implementation.
4. Knowledge of International GxP regulations (e.g. 21 CFR Part 11, 211,820, PIC/s), as well as Sarbanes-Oxley, HIPAA, and privacy regulations.
5. Experience with use/control of Electronic Records/Electronic Signaturesand electronic submissions to regulatory agencies.
6. Strong technical background--both from an application and infrastructureperspective.
7. Experience working in a highly regulated environment; GxP, QSR frameworkpreferred.
8. Solid project organizational skills. Ability to multi-task. Must havestrong analytical problem solving skills.
9. Excellent communication including written, verbal, and listening skills.
10. Self-motivated, detail oriented, takes initiative and ability to workindependently without close supervision.
11. Knowledge of ERP or SAP system function, business use and validation.DSR is currently seeking a candidate for a one year contract with an opportunityfor extension: Must have the following required skills:

Keywords: Dynamic Systems Resources, Chicago , Validation Lead, Other , Chicago, Illinois