Req ID: 381643 

NTT DATA 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 Operations Specialist (Kneat Platform Operations) to join our team in Hyderabad, Telangana (IN-TG), India (IN).

Job Description – Operations Specialist (Kneat Platform Operations)

Job Title: Operations Specialist – Kneat Platform Operations
Location: Hyderabad, client office, 5 days a week
Experience: 5–8+ Years
Domain: Pharmaceutical / Life Sciences / Healthcare (GxP Environment)

Job Summary

We are seeking an experienced Operations Specialist to support the governance, administration, and operational management of the Kneat validation platform within a regulated GxP environment. This role is responsible for ensuring the platform remains stable, compliant, secure, and operationally efficient by overseeing platform governance, administration, user management, incident management, change control, patch and upgrade coordination, and audit readiness.

The ideal candidate will have experience supporting validated digital quality systems, collaborating with cross-functional IT and business stakeholders, and maintaining compliance with pharmaceutical industry regulations and quality standards.

Key Responsibilities

Platform Governance & Operations

• Own and support the day-to-day operational governance of the Kneat platform.
• Ensure platform operations align with organizational governance standards, compliance requirements, and business objectives.
• Monitor platform health, operational performance, and service continuity.
• Participate in periodic governance meetings and operational reviews.

Platform Administration

• Provide administration oversight for platform activities, including access management, configuration coordination, and operational support.
• Coordinate platform administration activities while ensuring adherence to approved procedures and security policies.
• Maintain platform configuration documentation and operational records.

User Access Management

• Manage the complete user lifecycle, including:
  • User creation and onboarding
  • Access modifications and role updates
  • User deactivation
• Ensure user access complies with security policies, segregation of duties, and GxP requirements.
• Maintain user access records and support periodic access reviews.

Patch, Upgrade & Change Management

• Coordinate periodic platform patches, upgrades, and maintenance activities with vendors and IT teams.
• Assess operational impact of upgrades and facilitate required change control activities.
• Raise and track change requests, ensuring implementation follows established governance and validation processes.
• Support post-upgrade verification and operational readiness.

Incident & Service Management

• Monitor incidents, service requests, and operational issues.
• Coordinate issue resolution with internal support teams and external vendors.
• Track SLA performance and ensure timely resolution of incidents.
• Escalate critical issues and risks to appropriate stakeholders.
• Analyze service trends and recommend continuous improvement initiatives.

Compliance & Audit Support

• Support internal audits, customer audits, and regulatory inspections.
• Maintain operational documentation to demonstrate compliance with GxP requirements.
• Coordinate responses to audit observations and support corrective actions.
• Ensure platform operations follow controlled processes and validated system practices.

Stakeholder & Vendor Coordination

• Collaborate with IT Infrastructure, Quality, Validation, Business, and Vendor teams.
• Coordinate platform changes, operational reviews, risk assessments, and compliance activities.
• Communicate platform status, operational priorities, and service updates to stakeholders.
• Support governance reporting and executive operational reviews.

Continuous Improvement

• Track operational metrics, incidents, deviations, and service trends.
• Identify opportunities to improve platform stability, efficiency, and user experience.
• Recommend process improvements aligned with ITIL and operational best practices.

Required Skills & Experience

Technical & Functional Skills

• 5+ years of strong understanding of regulated GxP/GMP environments and controlled system operations.
• 5+ years of experience supporting Kneat validation platform operations, administration, or governance.
• 5+ years of experience with validated business systems, digital quality systems, or validation management platforms.
• Knowledge of:
  • Platform governance
  • User administration and access management
  • Patch and upgrade management
  • Change Management
  • Incident Management
  • Service Management
  • Audit readiness
  • Operational compliance
• Experience coordinating vendors and cross-functional IT teams.
• Understanding of system lifecycle management within regulated environments.

Regulatory Knowledge

• Good understanding of:
  • GxP
  • GMP
  • GAMP 5
  • 21 CFR Part 11
  • EU Annex 11
  • Computer System Validation (CSV)
  • Data Integrity (ALCOA+ principles)

Soft Skills

• Strong analytical and problem-solving skills.
• Excellent stakeholder management and communication skills.
• Ability to coordinate multiple operational activities simultaneously.
• Strong documentation and organizational skills.
• Ability to work independently while collaborating across global teams.
• Continuous improvement mindset with attention to detail.

Preferred Qualifications

• Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field.
• Experience supporting Kneat Gx or other electronic validation lifecycle management platforms.
• ITIL Foundation certification is preferred.
• Experience in Pharmaceutical, Biotechnology, Medical Device, or Healthcare organizations.
• Familiarity with ITSM tools such as ServiceNow or equivalent.
• Experience supporting validated cloud-based applications is an advantage.

About NTT DATA

NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.

Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com, @nttdatafed.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, https://us.nttdata.com/en/contact-us.

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