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Validation Expert at NTT Data, Inc

Posted in Other 30+ days ago.

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Type: Full Time
Location: Canonsburg, Pennsylvania

Job Description:

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees are key factors in our company s growth, market presence and our ability to help our clients stay a step ahead of the competition. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here.

NTT DATA, Inc. currently seeks a SAP Validation Lead\\" to join our team in Pittsburg, PA .

Day to Day job Duties:

We are looking to add a Senior SAP Validation Lead into our SAP Rollout project for a HLS Client. In this detail oriented role, resource must be: conversant with the SAP in an FDA regulated environment, have working knowledge of typical QC and have a thorough understanding of HLS industry best practices for validating SAP Software. This experience and understanding will provide a basis from which the candidate can work with QA and IT Consultants to lead validation projects and create validation lifecycle documentation including:
User and Functional Requirements and Specifications
Validation Plan
Risk Assessments (e.g., functional, Part 11, design, etc.)
IQ/OQ/PQ Testing
Configuration Specifications
Trace Matrices
Validation Summary Report
Support validation activities for GxP Production Applications:
Develop validation deliverables including but not limited to Validation Plans User Acceptance Test Designs User Acceptance Test Scripts.
User Acceptance Test Reports Traceability Matrices AFU/Validation Reports - Tracking, execution, review and archival of documents - Investigation and closure of anomalies encountered during testing.
Coordination with business users and developers to ensure business and regulatory requirements are adequately satisfied by software solutions.
Develop and execute Validation Plans, validation deliverables (IQ, OQ, PQ), requirement traceability matrix, URS/FRS, and Validation summary reports for computerized systems.
Develop validation master plans/project plans (VMP), revalidation plans and standard operating procedures (SOP) as necessary.
Tracking, execution, review and archival of documents o Investigation and closure of anomalies encountered during testing.
Coordination with business users and developers to ensure business and regulatory requirements are adequately satisfied by software solutions.
Support internal and external audits and inspections.
The Resource should be detail oriented team player with excellent communication skills as well as the ability to work well under pressure and meet deadlines in a timely fashion. He must be a motivated self-starter and possess the following abilities, experience, and knowledge. Ability to work within a team setting, lead validation activities, and be an individual contributor.

Basic Qualifications: (what are the skills required to this job with minimum years of experience on each)
6-8 years in Quality Validation experience in validation of computerized systems (SAP Systems etc.), interfaces, data migration and reporting.
5+ years: Documentation Practices, Computer System Validation (e.g., GAMP 5), and the software development lifecycle

Experience in user acceptance testing of regulated computer systems Experience in user acceptance script writing Experience in test script execution Good Documentation practices Knowledge of SDLC Experienced in computer validation methodology.
Understanding of document management principals.
Demonstrated technical writing and oral communication skills.
Ability to prioritize work in a fast-paced, deliverables oriented department.

Degree: : Bachelor s degree in a Laboratory Science(Biology, Chemistry, or Microbiology), or Computer Science with a colligate background in laboratory sciences, or 7-10 years of experience validating laboratory software systems in an FDA, GxP regulated environment.

Travel: Preference is for locals and USC or GC holder but the resource may need to travel to Europe

This position is only available to those interested in direct staff employment opportunities with NTT DATA, Inc. or its subsidiaries. Please note, 1099 or corp-2-corp contractors or the equivalent will NOT be considered. We offer a full comprehensive benefits package that starts from your first day of employment.

About NTT DATA

NTT DATA, Inc. partners with clients to navigate and simplify the modern complexities of business and technology, delivering the insights, solutions and outcomes that matter most. We deliver tangible business results by combining deep industry expertise with applied innovations in digital, cloud and automation across a comprehensive portfolio of consulting, applications, infrastructure and business process services. NTT DATA, Inc. is part of the NTT DATA family of companies, together comprising a top 10 global business and IT services provider with 100,000+ professionals in more than 50 countries, and is part of NTT Group, a partner to 85 percent of the Fortune 100. Learn more at www.nttdata.com/americas.

NTT DATA, Inc. (the Company ) is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.