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 on-site 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 setting 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