Computer System Validation, Risk Assessment to identify governing regulations and validation deliverables.
Handling GAMP5 and regulatory guidelines such as 21 CFR Part 11, EU Annex 11
Developing, reviewing CSV, User Requirement Specifications URS, Functional Requirements Specification FRS, IQ, OQ Requirement Traceability Matrix RTM Documents.
SOP Preparation & Maintaining 21 CFR Part 11 compliance for all GMP Systems.
Implementation of Serialization Track and Trace reporting
Best Practices - Policies, Processes, SOPs Documentation
Active Directory (GPO, DNS,DHCP, WINs, Replication, Capacity planning.etc)
Exchange & Office365 (Migration, DAG, Mailflow, Activesync, Routing, HA, Spam filter, Capacity planning etc)
Windows Servers (DFS, WSUS, IIS, RDS, PrintServer, File Server, Hyper-V, VPN, Cluster etc)
VMware ESXi (Implementation and Troubleshoot , P2V, V2V, VDR, VCenter, HA, Vmotion, Capacity planning etc)
Backup (Veeam, Symantec Exec or Netbackup)
Storage (EMC, IBM Netapp, HP Storage)
Antivirus (Symantec EP protection & MacAfee EPO) - Implementation, Configuration & Manage
Network (HP/CISCO, Aruba ClearPass ) VLAN, Virtual Chase, Wi-Fi Router, AD Integrated Wi-Fi, Firewall Policies , Route addetc.
Database SQL (Implementation and Troubleshoot)
• Bachelor s degree in Engineering with 7-10 Years of Total experience out of which minimum 5 years experience in the Pharmaceutical industry.
• Should have Certification in MCITP/MSCE, CCNA/CCNP.
• Must have a Valid Passport and ready to relocate to Saudi Arabia.