GxP CSV Validation Specialist – Pharma IT

Sun Pharmaceutical Industries, Inc.; Hinoba-an; On-site; PHP 900,000 - 1,700,000; Full time

Job summary

Sun Pharma is hiring a Validation Specialist at the Toansa site. The role oversees the Plant GxP Application Inventory and acts as Technical Owner for CSV documentation related to GxP applications. You will conduct CSV and QMS activities across the system lifecycle and support audits with detailed process explanations.

The candidate will validate IT systems, ensure compliance with GSOPs, SOPs, and regulatory requirements, and drive remediation efforts with cross-functional teams.

Qualifications

• BE/BTech or MCA with IT-focused degree and relevant certifications.
• Experience with validated GxP systems and CSV lifecycle.
• Familiarity with GMP/Regulatory requirements and IT infrastructure.

Responsibilities

• Manage the Inventory of GxP Applications for Manufacturing & Quality IT.
• Support validation deliverables planning and reviews for CSV projects.
• Prepare, review and approve CSV documents as Technical Owner.

Skills

Computer System Validation

IT regulatory requirements

Validation & Qualification

Education

BE/B.Tech, MCA, BCA, MSc IT, BSc IT + PGDCA

Tools

Trackwise

Validator

EDMS

Job description

Sun Pharma is hiring a Validation Specialist at the Toansa site. The role oversees the Plant GxP Application Inventory and acts as Technical Owner for CSV documentation related to GxP applications. You will conduct CSV and QMS activities across the system lifecycle and support audits with detailed process explanations.

The candidate will validate IT systems, ensure compliance with GSOPs, SOPs, and regulatory requirements, and drive remediation efforts with cross-functional teams.