Senior Manager- Information Technology

Role & responsibilities

1. OVERALL RESPONSIBLE FOR COMPLIANCE RELATED TO 21CFR PART 11 AND IT.
2. MONITOR AND MAINTAIN IT INFRASTRUCTURE, NETWORK, AND SECURITY DEVICES OF PLANT.
3. RESPONSIBLE TO MAINTAIN MAXIMUM UPTIME OF MAJOR IT SERVICES.
4. MONITOR AND LIAISING WITH VENDORS AND ISPES FOR ANY IT RELATED CONCERN.
5. ENSURE DOMAIN BASED SYSTEM SECURITY IMPLEMENTED IN GXP SYSTEMS.
6. IMPLEMENTATION AND REVIEW, ADHERENCE OF IT SOPS, POLICIES AND GUIDELINES.
7. RESPONSIBLE FOR THE MANAGE OVERALL IT INFRASTRUCTURE, GXP COMPLIANCE, CYBER SECURITY ASPECTS AND OTHER IT COMPLIANCE.
8. ENSURE IT SUPPORT, REVIEW OF CSV DOCUMENT FOR CSV ACTIVITY, IT QMS, INCIDENT AND OTHER DOCUMENTATION.
9. RESPONSIBLE TO PARTICIPATE IN CSV ACTIVITY FOR PRODUCTION AND QCC INSTRUMENTS SYSTEM INCLUDES PLC/SCADA AND HMI SYSTEM AND LABORATORY.
10. ENSURE DISASTER RECOVERY, BACKUP RESTORATION OF BACKUP DATA.
11. END-USER ANTIVIRUS SECURITY AND PATCH MANAGEMENT.
12. BIOMETRICS AND SURVEILLANCE SYSTEM MANAGEMENT.
13. ENSURE IT SYSTEM SECURITY AND POLICIES IN COMPUTERIZED SYSTEMS IN QC LAB AND MANUFACTURING SYSTEM.
14. ENSURE USER LIFE CYCLE MANAGEMENT FOR SYSTEMS AT PLANT.
15. GXP SYSTEM DATA BACKUP RESTORATION AND DISASTER RECOVERY PROCESS TO BE FOLLOWED.
16. TO SUPPORT WHILE REVIEWING OF AUDIT TRAIL DATA IN QC LABORATORY.
17. PRESENT IT SYSTEMS WHILE ANY EXTERNAL AND INTERNAL AUDIT IS CONDUCTED AT SITE.