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Validation Risk Analyst
Ref No.: 18-03057
Location: Whitehouse Station, New Jersey
NTT DATA, Inc., a top 10 global IT services company, has a Validation Risk Analyst need for our client in Whitehouse Station, NJ.

To apply for this position, please follow the link below or send your resume directly to
Kim.Ladka@nttdata.com. For more information please call Kim Ladka at 732-362-2602.

Job Responsibilities:
  • Act as Validation and Qualification Lead on a large global GMP QC Laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems.
  • Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
  • Assist systems users with defining and documenting system use in user, admin, and on validation and qualification documentation.
  • Proactively maintenance SOPs.
  • Coordinate alignment of systems users from various company sites, including international sites,
  • communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively.
  • Provide tactical guidance and coaching in support of systems testing efforts.
  • Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.
Job Qualifications:
  • 7+ years of Lab Systems CSV experience is required; or 5+ years as user of Lab Systems with 7+ years of other CSV experience.
  • Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical GMP QC Lab Standalone COTS systems are required.
  • Understanding of Data Integrity concepts is required.
  • Experience working with systems users from different sites is required. Experience with international sites is highly desired.
  • Excellent communication and written skills are required.

NTT DATA Services is a leading IT services provider and global innovation partner with 130,000 professionals based in over 50 countries. NTT DATA recently acquired Dell Services. NTT DATA Services emphasizes long-term commitment and combines global reach and local intimacy to provide premier professional services, including consulting, application services, business process, IT outsourcing, and cloud-based solutions. We are a part of NTT Group, one of the world's largest technology services companies, generating more than $100 billion in annual revenues and partner to 80% of the Fortune 100. Visit www.nttdataservices.com to learn how our consultants, projects, managed services, and outsourcing engagements deliver value for a wide range of businesses and government agencies.

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.