Executive - IT CSV

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

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2)????? REPORTING TO: Immediate superior (Manager )???

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3)????? JOB RESPONSIBILITIES :

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?? 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

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?? 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.

?? 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.

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