1. Preparation, execution and review of computer system validation protocols and reports.
2. Preparation and management of CSV deliverables for laboratory instruments and systems, manufacturing equipment, utility systems, IT, and enterprise systems.
3. Ensure the Computer System Validation is in alignment with the Validation Master Plan for Computer Systems.
4. Ensure timely completion of all validation related activities including computer system, equipment, utilities, and facility with compliance.
5. Perform assessment of vendor documents for CSV deliverables.
6. Conduct risk assessments to identify potential risks associated with computerized systems, including data integrity, security, and regulatory compliance.
7. Preparation and review of standard operating procedures to establish and maintain the quality system of the organization.
8. Participate in CFT meeting related to IT systems and ensure the completion of pending actions.
9. Periodic Review of IT application and systems implemented and compilation of reports.
Education and Experience
Diploma or Degree in IT or equivalent.
A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.
Experience in electronic validation system, QMS, ERP system, SCADA, is preferred.
Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.
