Company: Dynamic Systems Resources
Posted on: January 27, 2023
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
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
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
14. Knowledge of testing tools like TestDirector, WinRunner,
LoadRunner,Rational RequisitePro, Rational TestManager, Rational
Robot, Rational ClearQuest,RUP, Rational SoDA for Word,
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 /
4. Knowledge of International GxP regulations (e.g. 21 CFR Part 11,
211,820, PIC/s), as well as Sarbanes-Oxley, HIPAA, and privacy
5. Experience with use/control of Electronic Records/Electronic
Signaturesand electronic submissions to regulatory agencies.
6. Strong technical background--both from an application and
7. Experience working in a highly regulated environment; GxP, QSR
8. Solid project organizational skills. Ability to multi-task. Must
havestrong analytical problem solving skills.
9. Excellent communication including written, verbal, and listening
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
Keywords: Dynamic Systems Resources, Chicago , Validation Lead, Other , Chicago, Illinois
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