Role & responsibilities

We are seeking an experienced CSV Lead to manage and execute computer
system validation activities across global projects in the pharmaceutical domain. The
ideal candidate will have in-depth knowledge of regulatory compliance (e.g., GxP, 21
CFR Part 11), solid documentation skills, and hands-on experience in global
implementation projects. This role requires close collaboration with cross-functional
teams including IT, QA, Regulatory, and Business stakeholders.

Key Responsibilities:
• 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.
• Robust 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.

Preferred Qualifications:
• Bachelor's/Masters degree in Pharmacy, Life Sciences, Computer
Science, or related discipline.
• Certifications such as GAMP, PMP, or Six Sigma will be an added advantage.

📌 Computer System Validation Engineer Ahmedabad
🏢 TeamLease
📍 Ahmedabad