Assistant Manager
7 days ago
Sr. No.
Job Responsibilities
Responsible for IT compliance in terms for Regulatory requirements i.e., USFDA, EU, MHRA, Russia, Brazil and ROW.
Ensure all computerized systems are validated as per CSVMP and maintain throughout lifecycle.
New SOP creation and maintenance of existing SOP and their compliance.
Support SAP users in Day-to-Day transactions and troubleshooting.
Maintain all Document related to GMP and 21 CFR Part 11.
Backup Monitoring and restore verification GxP computerized System.
User management of all computerized system.
IT related QMS activities i.e. Change Control, incident, CAPA, Audit preparation.
Ensure all computers connected with GxP Systems are secured and restricted in terms of regulatory compliance and Data Integrity.
10.
IT Asset Management.
11.
Any other activity assigned with seniors.
12.
To perform the activity on behalf of IT department head / designee.
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