Technical Lead Jobs Opening in For a Client of TeamLease Digital at Kulgam
FEATURED JOBCSV Lead
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Job Description
Job Summary:
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), strong 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.
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.
