KEY DUTIES AND RESPONSIBILITIES
- Preparation, execution and review of computer system validation protocols and reports.
- Preparation and management of CSV deliverables for laboratory instruments and systems, manufacturing equipment, utility systems, IT, and enterprise systems.
- Ensure the Computer System Validation is in alignment with the Validation Master Plan for Computer Systems.
- Ensure timely completion of all validation related activities including computer system, equipment, utilities, and facility with compliance.
- Perform assessment of vendor documents for CSV deliverables.
- Conduct risk assessments to identify potential risks associated with computerized systems, including data integrity, security, and regulatory compliance.
- Preparation and review of standard operating procedures to establish and maintain the quality system of the organization.
- Participate in CFT meeting related to IT systems and ensure the completion of pending actions.
- 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.
