Company: Dynamic Systems Resources
Posted on: February 25, 2021
Summary & Key Responsibilities:
Develop system development life cycle documents related to global
ERP system. This includes system specification documents,
validation plans and test protocols, and procedures. Work with
regional project teams to ensure global validation strategy is
understood and followed. Develop development programming standards
as needed. 1. Act as Validation Lead as assigned for Global US
Implementation or Region for 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,
Functional and Design Specifications. Provide guidance in
generation of hardware system specifications.
4. Gain understanding and follow defined SDLC. Ensure quality
validation processes are executed as defined by procedures.
5. Using risk-based approach to validation, determine testing,
documentation and verification activities, with appropriate
justification of the approach.
6. With team, develop validation strategy for
components/workstreams that comprise the ERP system. Deploy
strategy, defining documentation requirements and hierarchy for
7. Manage electronic routing of required documentation*ensuring
compliance to current procedure for e-approval.
8. Communicate status, solutions and concerns. Disseminate
information in a timely manner within the team. Facilitate and
address issues within project.
9. Manage validation team*coordinating documentation and testing.
Generate test scripts, as needed. Execute testing as required.
10. Collaborate with business, quality, and technical individuals
throughout project 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, GUI Testing, Functionality Testing, Security Testing,
System Testing, Regression Testing, Integration Testing,
Performance/Stress Testing, User Acceptance Testing, 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 healthcare industry. At least 5-7 years validation experience
in both infrastructure qualification and application
3. Proven results in managing validation aspect of software /
infrastructure project 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
5. Experience with use/control of Electronic Records/Electronic
Signatures and 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
have strong analytical problem solving skills.
9. Excellent communication including written, verbal, and listening
10. Self-motivated, detail oriented, takes initiative and ability
to work independently 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 opportunity for extension: Must have the following
Keywords: Dynamic Systems Resources, Chicago , Validation Lead, Other , Chicago, Illinois
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