We are looking for an experienced Computerized System Validation (CSV) professional with proven hands-on experience working on overseas pharmaceutical/life-sciences projects.

The candidate should have previously worked directly with international clients, preferably through in office overseas assignments, and should be comfortable independently managing CSV deliverables, client discussions, validation execution, and audit/compliance activities.

Key Responsibilities

- Execute end-to-end CSV activities for GxP computerized systems.
- Interact directly with overseas clients and stakeholders.
- Prepare and review URS, FS/DS, Risk Assessments, Validation Plans, IQ/OQ/PQ, Traceability Matrix and Validation Summary Reports.
- Perform GxP impact assessments and risk-based validation.
- Execute validation/testing activities at client sites.
- Support deviations, change controls, CAPA and audit-trail reviews.
- Assess systems for 21 CFR Part 11, EU GMP Annex 11 and Data Integrity/ALCOA+ requirements.
- Coordinate with global QA, IT, Engineering,



Business Process Owners and system vendors.
- Support regulatory inspections and client audits.
- Provide project status updates and independently manage assigned validation activities.

Qualifications & Required Skills

- Bachelor's/Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Engineering, IT, Computer Science or related discipline.
- 4+ years of experience in related field
- Proficient in Microsoft Office
- Strong communication and presentation skills
- Ability to work in a high-paced environment and manage multiple projects
- Minimum 1 completed overseas CSV project.
- Excellent written and verbal English communication.
- Willingness to travel internationally for project assignments.
- Strong understanding of pharmaceutical GxP environments.

? Apply Now

? Email: [email protected]

? Contact: +91 (phone hidden)

📌 Senior CSV Consultant (Overseas) (Indore)
🏢 Instrumentationntrol Solutions
📍 Indore