IT Site Lead

2 weeks ago


Johor Bahru, Johor, Malaysia Biocon Biologics Full time

RESPONSIBILITIES:

Site OPS IT Lead at Malaysia facility to drive team of consultant engineers to provide support for manufacturing with respect to process systems Admin rights related activities in coordination with CFT.

  1. Managing team of consultant engineers to ensure 24/7 support to Manufacturing.
  2. Maintain the systems always at compliant state.
  3. Protocols & SOPs preparation & review as applicable.
  4. Handling SAP Plant maintenance module.
  5. Having hands on with QMS modules such as Track wise, eVMLS, DMS, etc.
  6. Maintain inventory list of Manufacturing Automated System.
  7. Ensure the engineers performing / participating into qualification and validation of Manufacturing Automated systems from IT for various IT admin roles.
  8. Review of qualification and validation documents of Manufacturing Automated systems including SCADA system from IT perspective covering 21 CFR Part-11 applicability, ER/ES, User & Role Management, Software Categorization, and Audit trail.
  9. Ensure the engineers providing IT administrative support on Operating Systems (OS) & Application Software of Computer Servers, Desktops, Laptops, Industrial PCs, and Handheld devices used in Manufacturing Automated Systems including SCADA systems at Site.
  10. User Management (Creation, Modification, Password reset, etc.).
  11. User Access Rights Management on various drives, files, and folders.
  12. Date and time Management.
  13. OS Policy Management.
  14. Backup & Restoration Management.
  15. Installation/ upgradation of Operating System, OS Service Pack/ Patch Management.
  16. Antivirus Management (if applicable).
  17. Periodic review of security audit trails & event logs (as applicable).
  18. Provide support to vendor/OEM for fixing IT related issues during breakdowns.
  19. Upgradation of software, service packs, deployment of hot fixes, patches, etc.
  20. Provide assisted admin access to QA/Regulatory authorities during audits (if applicable).
  1. Initiation of QMS as per IT Operation requirements, investigation, CAPA implementation.
  2. Participate in internal and external Audits to respond on IT related points for manufacturing Automated Systems.
  3. Ensures the electronic data security of the system administration.
  4. Ensure the availability of procedures to maintain the system for Archival and Retrieval of data.
  5. Responsible for supporting system specific risk mitigations.
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