Sr. Consultant Jobs Opening in NTT Data Business Solutions Private Limited at Ahmedabad

FEATURED JOB

CSV

NTT Data Business Solutions Private Limited

8 to 10 Years

150000 - 300000 Monthly

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Posted: 06 Jul 26

Job Description

 Lead and manage Computer System Validation (CSV) activities for GxP
systems in line with FDA 21 CFR Part 11, Annex 11, and other applicable
regulations.
 Ensure validation of systems across global project landscapes, including
ERP (SAP), LIMS, MES, TrackWise, and other laboratory/enterprise systems.
 Prepare and review validation deliverables such as Validation Plans, Risk
Assessments, IQ/OQ/PQ protocols, Traceability Matrix, and Validation
Summary Reports.
 Collaborate with IT, Quality Assurance, and system owners to ensure
compliance with internal policies and international regulatory standards.
 Support audit readiness and participate in regulatory inspections or internal
audits.
 Establish and maintain CSV SOPs and templates, and provide training to
internal teams.
 Act as a subject matter expert (SME) for CSV in global pharma projects.
 Manage validation project timelines, resources, and deliverables effectively.

Required Skills & Experience:

 Minimum 8 years of experience in Computer System Validation within the
pharmaceutical/life sciences industry.
 Proven experience in handling global implementation/rollout projects.
 Strong knowledge of GxP, FDA 21 CFR Part 11, GAMP 5, Annex 11, and
other relevant regulatory guidelines.
 Experience with validated systems such as SAP, LIMS, MES, QMS (e.g.,
TrackWise) is highly desirable.
 Excellent documentation, analytical, and communication skills.
 Experience with risk-based validation approaches and ALCOA+ data
integrity principles.
 Ability to manage multiple validation projects and lead cross-functional teams.