Executive - IT CSV

1. JOB SUMMARY : Responsible for IT compliance and Computer System Validation Activity

2. REPORTING TO: Immediate superior (Manager )

JOB RESPONSIBILITIES :

Ø Computerized system validation

· Administer, Implement, Validate and Facilitate Testing of different GxP Applications at Site

· Develop and Maintain Validation Plans, Test Plans, Validation Protocols, Validation Summary Reports, User Requirements, Administration SOP’s and other related validation documents for Computerized systems

· Initiate, Review and Approve Quality Risk Assessments, Change Requests, for any SOP’s related to computerized systems

· Provide guidance on CSV (Computer System Validation) issues and discrepancies and support investigation of CSV defects and Quality Records (deviations and CAPA’s)

· Provide support to internal and external audits related to CSV activities

· Maintain internally or externally hosted GxP Applications in a validated state

· Manage Contractual resources and Managed Service Providers with projects and ongoing validation needs

· Author and revise validation documents such as SOP’s, Protocols and work instructions related to computerized systems

· Administer GxP systems

· Assist as needed in Audits and Inspections

· Contribute to projects related to QA CSV improvements and system reliability

· Partner with QA to manage systems validation, periodic reviews and vendor assessments

· Act as a subject matter expert for CSV related matter

· To perform any other works as and when assigned by Head of department.

· To act as Administrator for all GXP IT systems at Site

Ø Risk Assessment and Mitigation:

· Perform risk assessments to identify potential vulnerabilities and risks to data integrity.

· Collaborate with cross-functional teams to develop and implement risk mitigation strategies and controls.

· Proactively identify and address data integrity risks in existing processes, systems, and practices.

Ø Documentation and Record-Keeping related to IT control.

· Establish and maintain proper documentation and record-keeping systems to support data integrity.

· Ensure that documentation practices comply with regulatory requirements and good documentation practices (GDP).

· Oversee the review and approval of data-related documents, such as standard operating procedures (SOPs) and validation protocols.