Quality Assurance Analyst - IT Compliance & CSV

Key Responsibilities :

• Ensure compliance with GAMP 5 guidelines for system validation and development.
• Create, review, and maintain SOPs, Policies, Guidelines, and Procedures related to quality assurance.
• Perform internal audits and assist in preparing for and facing external audits (regulatory or client).
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GDPR, and other relevant global regulations.
• Lead investigations and manage documentation for Deviations and CAPAs.
• Support IT GxP system compliance, ensuring systems are validated and maintained per

regulatory expectations.

Required Skills & Qualifications :

(ref : hirist.tech)