|Date Posted||March 10, 2018|
NTT DATA, Inc., a top 10 global IT services company, has an immediate need for an
Sr. Validation Risk Analyst to support our client in Branchburg, NJ
To apply for this position, please follow the link below or send your resume directly to [Click Here to Email Your Resumé] For more information please call Melissa Torrisi at
Contract - 1 year
Sr.Validation Risk Analyst
- Under the direction of a Validation Risk Partner, ensure the technical integrity of a product or system from a compliance perspective.
- For regulated and/or non-regulated systems, as the SDLC subject matter expert, author plan and summary SDLC deliverables (e.g., Quality Assurance Plan or Change Plan, Development and Test Plan, Acceptance Test Plan, and Development Summary Report, Acceptance Test Summary Report, and Quality Assurance Summary Report or Change Summary).
- Review SDLC deliverables upon request to ensure adherence to SDLC, policies and procedures, and system specific planning documents.
- Coordinate the required assessments for new systems (e.g., Risk Profile, Security, Privacy, Supplier, etc.)
- Partner with assigned Business Unit, Technical Unit including internal and external developers, Quality Unit, and testing representatives on project teams ensuring strategic approach is followed.
- Build and maintain a positive, collaborative relationship across all disciplines
- Understand and apply a risk based approach to validation activities and testing
- Assist Project manager in developing project schedule as it relates to required SDLC activities
- Provide SDLC and regulatory guidance to other level Validation Risk Specialists
- Provide guidance on corporate policies, procedures and assessments
- A minimum Bachelor's degree in a science or technology discipline
- 8+ years of industry experience including computer system validation, SDLC, Validation, and/or QA experience.
- Experience working in a Pharmaceutical environment in a regulated (GxP) environment
- High level of expertise in computer system validation regulations including 21 CFR Part 11, Part 58, Part 210, Part 211 and Part 820 is required. Knowledge of the EU Annex 11 regulations is preferred.
- High level of expertise in SDLC methodology (e.g., waterfall, agile, spiral) including change management
- Excellent written and communication skills including thorough knowledge of Good Documentation Practices
- High level of experience in managing and conducting change control, validation planning and summarization
- High level of experience writing Quality Assurance or Validation Plans and Summaries as well as change plans and change summaries
- High level of experience providing guidance for adherence to SDLC and corporate and regulatory procedures.
- High level of experience in ITIL change management and SOPs supporting this process
- Previous experience with Remedy or comparable tool for asset and change management
- Experience with software such as document management and automated testing tools (e.g., First Docs (Documentum), HP Quality Center/Application Lifecycle Management).
- Ability to prioritize and manage multiple projects / efforts concurrently.
- Excellent interpersonal skills including ability to work as a team member in a collaborative environment
- with minimal supervision.
- High attention to detail.
- Specialist needs intimate knowledge of end-to-end validation process and strong familiarity with SDLC deliverables. Preferred experience with validation of:
- retrospective validation
- Clinical systems
- Appian software platform
- Blockchain technology
NTT DATA 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 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're 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.nttdata.com/americas 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. U.S. Citizens and those authorized to work in the U.S. are encouraged to apply. We are unable to sponsor at this time.