CSV Lead Analyst

Req ID: 277440

NTT DATA Services strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.

We are currently seeking a CSV Lead Analyst (Remote) to join our team in Ontario (CA-ON), Canada (CA).

Responsibilities

• Computer Systems Validation Leader / Manger is responsible for Quality oversight and management of Computer System Validation (CSV) in accordance with industry standards and regulatory guidance.
  • This is a hands-on oversight role that will be accountable for ensuring that Client’s computer systems are appropriately validated before release and remain in a compliant state throughout their life. This position requires a broad range of knowledge and a deep understanding of various rules and regulations as well as international standards and guidelines.
  • Maintain CSV and Computer System Change Control processes
  • Apply risk-based methodologies in the oversight of Computer validation and Instrument System qualification efforts
  • Provide leadership and guidance to NTT Data / Client personnel on CSV matters and ensure compliance to applicable industry regulations

• Maintain CSV templates

• Conduct GxP evaluations of new Computer and Instrument Systems
  • Work collaboratively across functions with Quality, IT, Business partners, and Vendors to plan, coordinate, and execute CSV activities
  • Review CSV lifecycle documentation from a Quality perspective and approve as Quality representative
  • Oversee formal test execution to ensure the testing was performed appropriately and the test results are compiled in a timely manner
  • Review and approve System-specific Administration and User SOPs
  • Oversee the readiness of the CSV program to ensure Computer Systems are compliant and ready for regulatory reviews
  • Be the QA CSV Subject Matter Expert (SME) in support of audits and regulatory matters
  • Provide guidance and direction throughout the GxP Computer and Instrument System Change Control process
  • Ensure appropriate standards and practices are implemented for the collection, use, transfer, storage, and deletion of personal information in GxP Computer and Instrument Systems
  • Perform Quality oversight and approval of periodic user access review
  • Ensure CSV lifecycle documentation is completed and filed appropriately
  • Maintain and present applicable metrics and key performance indicators
  • Review of application vendor's qualification and/or validation documentation, as applicable
  • Work with vendors for change control management, incident management and issue resolution
  • Proactively identify and collate information required to assess compliance with processes and prioritize business process improvement needs.
  • Review, assess and update procedural documents for overall compliance with current processes, as required
  • Proactively collaborate with initiative leads and senior management to develop, optimize and improve CSV processes, training, and communications
  • Perform special projects, assignments, and administrative tasks per business needs
  • Provide guidance and review or create varied support materials, presentations, and/or tools to support department's remit and strategies.
  • Mentor, coach, and support team members

Education and Experience

• 10+ years of experience working in electronic based Computer System Validation in a GxP environment
  • Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process
  • Experience in employing risk-based approaches to CSV
  • Experience in qualification of GLP Instrument Systems
  • Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems
  • Experience in performing validation of cloud-based Computer solutions
  • Significant experience in authoring, reviewing and execution of validation and qualification documents, including test scripts.
  • Project management experience for regulatory projects
  • Knowledge of practices and procedures of the full software development life cycle

• Strong attention to detail

• Hands on experience with eDMS tools like Documentum or Master Control, as well as testing tools like Jira, ALM, etc.
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification or previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
  • GAMP, GxP and VLMS/eDMS application training (desirable)

Desirable Knowledge, Skills, and Abilities

• Strong knowledge of software development lifecycle, GAMP and CSV processes
  • Working knowledge of GxP, FDA, EU and other relevant regulatory requirements for Pharma, Biotech, and med devices.
  • Ability to develop/update validation project plans and computerized system lifecycle program documents to deliver large CSV projects
  • Significant experience in authoring, reviewing and oversight of the execution of CSV documents, including Validation Plan, functional and regulatory risk assessments, User/Functional/System/Data Migration Requirements, IQ/OQ/PQ protocols, test plans, test scripts and test reports, traceability matrices as well as Validation Reports.
  • Hands on experience with common tools and processes within the digital validation arena (Jira, ALM, Master Control, Documentum, First Doc, TX3, Kneat, ValGenesis, etc.)
  • Understanding and experience with automated testing, including tools like Tosca and Leap Work (desirable)
  • Good knowledge and experience with maintaining the validated state, including Change Management, CAPA, audits, etc.
  • Strong problem-solving, verbal, written and presentation skills
  • Computer literate with the ability to work within multiple databases
  • Proficient in Microsoft Office products (including Outlook, Word, and Excel)
  • Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
  • Ability to maintain a positive and professional demeanor
  • Ability to work effectively within a team to attain a shared goal

• Project management experience

About NTT DATA Services

NTT DATA Services is a recognized leader in IT and business services, including cloud, data and applications, headquartered in Texas. As part of NTT DATA, a $30 billion trusted global innovator with a combined global reach of over 80 countries, we help clients transform through business and technology consulting, industry and digital solutions, applications development and management, managed edge-to-cloud infrastructure services, BPO, systems integration and global data centers. We are committed to our clients’ long-term success. Visit nttdata.com or LinkedIn to learn more.

NTT DATA Services is an equal opportunity employer and considers all applicants without regarding to race, color, religion, citizenship, national origin, ancestry, age, sex, sexual orientation, gender identity, genetic information, physical or mental disability, veteran or marital status, or any other characteristic protected by law. We are committed to creating a diverse and inclusive environment for all employees. If you need assistance or an accommodation due to a disability, please inform your recruiter so that we may connect you with the appropriate team.

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