QA Lead

We are looking for a skilled Senior CSV Consultant with 6-8 years of experience to manage and execute computer system validation activities for a global project in the pharmaceutical domain. This position is based in Ahmedabad.

Roles and Responsibility

• 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, 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.
• 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.

Job Requirements

• Minimum 6-8 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 validating systems such as SAP, LIMS, MES, QMS (e.g., TrackWise).
• Good knowledge on different cross-functional ERP/SAP modules (e.g., MM, PP, QM, FICO).
• Exposure in Project tracking and electronic document management tools.
• Excellent documentation, analytical, and communication skills.
• Experience with risk-based validation approaches and ALCOA+ data integrity principles.
• Bachelor's or master's degree in pharmacy, Life Sciences, Computer Science, or related discipline.
• Certifications such as GAMP, PMP, or Six Sigma will be an added advantage.

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.