Arcolab is hiring experienced professionals for Computer System Validation (CSV) roles in Bangalore. If you have strong knowledge of GxP systems, 21 CFR Part 11, Annex 11, and IT operations within regulated environments, this is an excellent opportunity to grow your career in pharma and life sciences technology.
These openings are ideal for candidates with 2–10 years of experience in enterprise system validation, data integrity, audit trail review, and QMS event handling.
Key Responsibilities
- Prepare and execute CSV deliverables for enterprise systems.
- Conduct risk assessments and create/ review 21 CFR Part 11 & EU Annex 11 compliance reports for equipment and instruments.
- Perform periodic reviews, including user access, error logs, and audit trail verification.
- Manage and document QMS events in compliance with regulatory requirements.
- Understand and support IT operations, including data & security management, backup, and restoration processes.
- Ensure compliance during GxP system maintenance activities.
Required Qualifications
- MCA / B.Tech / Pharm degree
- Experience range: 2 to 10 years
- Strong understanding of CSV processes, GxP environments, and data integrity
- Familiarity with QMS tools and regulatory compliance frameworks
- Good analytical, documentation, and communication skills
Benefits of Working with Arcolab
- Opportunity to work in a regulated pharma IT environment
- Exposure to enterprise-level GxP systems and global compliance standards
- Skill development in advanced validation practices and IT quality processes
- Competitive salary and growth-oriented work culture
How to Apply
Interested candidates can send their resumes to:
📧 Dev.kiran@arcolab.com