Technical Lead Jobs Opening in For a Client of TeamLease Services Ltd. at Ahmadabad

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.

Preferred Qualifications:

• Bachelor's/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.