Senior Executive - IT Validation

The role holder will be responsible to execute and review the activities in compliance to CSV program, designated person shall have the self-driven approach in the capacity of computer system validations & associated areas.

Role & responsibilities

• Preparation, execution and reporting of GxP computerized systems validation deliverables at site.
• Ensure all validation activities adhere to regulatory requirements and company standards.
• Ensure compliance of all GxP computerized systems validation activities at the site.
• Maintain the validated state of all GxP computerized systems used at the site.
• Oversee end-to-end implementation of assigned projects, including tracking progress, following up on tasks, and managing escalations.
• Ensure self-inspection and remediation activities related to GxP computerized systems.
• Conduct periodic reviews of all GxP computerized systems at the site to ensure continued compliance.
• Provide inputs for the revision and implementation of Computerized System Validation (CSV) procedures.
• Manage associated QMS activities to ensure timely completion of action items, including Change Controls, Deviations, investigations, and CAPAs.
• Review protocols, QMS documents, CSV deliverables, and other related documents to ensure accuracy and compliance.
• Ensure the site is prepared for all audits and actively participate during audit processes.
• Provide training to cross-functional team (CFT) members on CSV-related procedures.
• Maintain an updated inventory of GxP computerized systems.
• Ensure that Annual Computerized System Validation Master Plan and Reports are managed as per annual schedules.

Preferred candidate profile

4 to 6 years of Previous experience in GxP computerized systems validation or a similar role. Strong knowledge of regulatory requirements and industry standards for GxP computerized systems