Website:
ics-india.co.in
Job details:
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 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: shivani.kumawat@ics-india.co.in
📞 Contact: +91 9109188512
Click on Apply to know more.
