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

?

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

?

3)????? JOB RESPONSIBILITIES :

?

?? 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

?

?? 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

📌 Executive - IT CSV (Baddi)
🏢 Panacea Biotec
📍 Baddi