CSV Validation Lead - GxP IT Systems Specialist

Sun Pharmaceutical Industries, Inc.; Hinoba-an; On-site; PHP 1,200,000 - 1,800,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in the Philippines seeks an experienced IT professional to manage the GxP Application Inventory and serve as the Technical Owner for CSV documentation across the system lifecycle.

You will oversee CSV/QMS activities from implementation to retirement, and support internal/external audits by explaining processes and documentation related to CSV and remediation.

Qualifications

• Educational background in IT/IT pharma related fields.
• Strong understanding of CSV/QMS regulatory requirements.
• Experience executing validation activities within pharma manufacturing.

Responsibilities

• Manage inventory of GxP applications for Manufacturing & Quality IT.
• Plan and review validation deliverables for CSV projects.
• Prepare, review and approve CSV documents as Technical Owner.
• Ensure compliance of GSOPs/SOPs for CSV documentation and regulations.
• Understand Trackwise, Validator and EDMS usage.
• Support audits with processes and documentation explanations.
• Coordinate during IQ/OQ/PQ with vendors.
• Identify continuous improvement opportunities for CSV projects.
• Control CSV document management and IT-related records.
• Ensure timely completion of validation activities without extensions.
• Maintain audit readiness with compliant documentation.
• Close out deviations, CAPA, change controls timely.

Skills

Computer System Validation

IT regulatory requirements

Validation & Qualification activities

Education

BE/B. Tech

MCA

BCA

MSc IT

BSc. IT

Graduation + PGDCA

Tools

Trackwise

Validator

EDMS

Job description

Sun Pharmaceutical Industries Ltd in the Philippines seeks an experienced IT professional to manage the GxP Application Inventory and serve as the Technical Owner for CSV documentation across the system lifecycle.

You will oversee CSV/QMS activities from implementation to retirement, and support internal/external audits by explaining processes and documentation related to CSV and remediation.