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- Fort Worth, TX
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Systems Validation / Quality (607957)
The Judge Group • Fort Worth, TX
Posted 1 month ago
- Understand and adhere to the Quality manual, SOP on Project Management, Change Management, Document Management and Quality Management;
- Support the Project Manager throughout the project delivery of the Enterprise Asset Project, with regards to aspects of project related risk, compliance and quality.
- Responsible together with Project Manager for the delivery of all defined QM documentation
- Establish, implement and monitor the QM requirements which assures that IT Projects meet Quality and Regulatory requirements
- First point of contact for all quality related queries on the project
- Author key validation deliverables
- Apply required internal and external Quality/Compliance standards to work products (Change control, validation documents etc)
- Ensure adequate analysis have been performed for relevant testing conditions based on functional risk assessment, test overview list, test plan, test results, test deviations and change requests.
- Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable
- Manage appropriateness of preparation and readiness of the project for handover of the system/processes to the operational organization together with the project managers
- Perform the project tollgate reviews and post implementation reviews with reporting to management
- 6 to 9 years relevant work experience in IT/QM compliance
- Excellent verbal communication skills, both written and oral, additional languages would be a plus
- GxP, 21 CFR Part 11, SOX, SOX IT knowledge, Data Privacy, Data Integrity, Security Risk assessment, periodic review
- System Development Life Cycle and Gamp Knowledge
- Knowledge on Waterfall and Agile methodology
- Able to manage direct relations with stakeholders and project team members
Brian K. Kubiak, Sr. Technical Recruiter, The Judge Group
90 Matawan Road, Suite 102, Matawan, NJ 07747
Direct Dial: 732.497.4294 | Email: firstname.lastname@example.org