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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

Job Snapshot

Full-Time
Experience - 6 to 9 years
Other Great Industries
QA - Quality Control, Inventory

Job Competition

3

Applicants

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Job Description

Our client is currently seeking a Systems Validation / Quality Consultants (607957) Long Term Contract, (C2C acceptable) (No Student Visa's) Local Candidates highly preferred, contact Brian Kubiak, 732.497.4294, bkubiak@judge.com

Job Skill Requirement:
  • 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

Required Experience:
  • 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: bkubiak@judge.com

linkedin.com/in/brian-k-kubiak-3593983

Job ID: 607957
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