1.     To maintain inventory list of Manufacturing Automated System including PLCs/SCADA System installed at site.

2.     Assist in 21 CFR Part 11 Assessment during Computerized System selection.

3.     Prepare and maintain IT related SOPs (as applicable) for Manufacturing Automated Systems including PLCs / SCADA Systems.

4.     Perform / participate into qualification and validation of Manufacturing Automated Systems including PLCs / SCADA Systems from IT for various IT Admin Roles.

5.     Review of qualification and validation documents of Manufacturing Automated Systems including PLCs / SCADA Systems from IT perspective covering 21CFR Part 11 applicability, ER/ES, User & Role Management, Software Categorization, Audit Trail etc.

6.     Ensure review of the documents related to site.

7.     To provide the IT Admin support on Operating Systems (OS) of Computer Servers, Desktops, Laptops, Industrial PCs, Hand Held Devices etc., which are used Manufacturing Automated Systems including PLCs / SCADA Systems at site.

For example:

a.       User Creation

b.      User Access Right Management on various drives, folders or files

c.       Date & Time Management

d.      OS Policy Management

e.       Backup

f.       Installation / upgrade Operating System, OS Service Pack / Patch management

g.       Anti - Virus Management (if applicable)

h.      Periodic review of event logs

i.        Provide support to vendor for fixing IT related issues during breakdowns