Industry Consulting Consultant

2 months ago

Pune, India NTT DATA Services Full time

Req ID: 276279 

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 Industry Consulting Consultant to join our team in Pune, Mahārāshtra (IN-MH), India (IN).

CSV Analyst

NTT Data is seeking a Computer System Validation Analyst experienced in Life Sciences GxP software validation.


Responsibilities
 

  • Operate as a key member of application upgrade and installation projects representing the CSV department in all project meetings and discussions.
  • Author, and manage the review and approval of key CSV deliverables including the Validation Plan, URS, FRS, DS, IQ/OQ/PQ, Traceability Matrix, Test Plans, and Reports, Validation Report in client or NTT eDMS or VLMS.
  • Work with client QA department to coordinate and ensure on-time delivery of all CSV deliverables.
  • Participate in all roll-out activities for the project and maintain relevant documentation
  • Work with stakeholders and business representatives to document requirements, qualifications and user acceptance test scripts that adequately ensure business requirements are met for a given system
  • Ensure close collaboration with appropriate system owners and key stakeholders in the business
  • Ensure that GxP applications maintain their validated state during the system lifecycle
  • Provide system audit support and ensure inspection readiness of applications
  • Work with QA, Computer Systems Validation Committee, and IT to document CAPAs, audit observations and other quality items
  • 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
 

  • 4+ years of experience working in electronic based Computer System Validation in a GxP environment 
  • Significant experience in authoring, reviewing and execution of validation and qualification documents, including test scripts.
  • 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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