Team Member

**Job Summary**

The Job holder will be responsible to support Manufacturing Systems for Inventory Management, 21CFR Part 11 Assessment, Support Qualification & Validation of PLC/SCADA systems, IT Admin support on Operating Systems (OS) of Computer Servers, Desktops, Laptops, Industrial PCs, and Hand Held Devices etc. and Backup Management, Instrumentation hardware service Support to PLC, HMI, IPCs, Network Cards, Connectors, and Cables etc.

**Areas Of Responsibility**
- 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

c. Date & Time Management

d. OS Policy Management

e. Backup & Restoration

f. Installation / upgrade of 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

j. Periodic review of security audit trails.

k. Provide support to external support team for fixing IT related issues during breakdowns
- Maintain inventory list of Manufacturing Automated System including PLCs/SCADA System installed at site.
- 21 CFR Part 11 Assessment and Implementation.
- Prepare and maintain IT related SOPs (as applicable) for Manufacturing Automated Systems including PLCs / SCADA Systems
- Perform / participate into qualification and validation of Manufacturing Automated Systems including PLCs / SCADA Systems from IT for various IT Admin roles.
- 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, and Audit Trail etc.
- Perform the data and program backup and retrieval of Manufacturing Automated Systems including PLCs / SCADA Systems as per applicable SOP(s) at site
- Participate in internal and external Audits to respond on IT related points for Manufacturing Automated Systems including PLCs / SCADA Systems
- Review & verification of Corrective Action Plan identified for Manufacturing Automated Systems including PLCs / SCADA Systems during internal and external audits.
- Installation, configuration and management services for Desktop, Laptop, IP Telephones, Handheld terminals etc.
- Installation and user support for Operating systems, Office automation packages and IT Applications.
- Computer system validation of IT Infrastructure and compliance to IT process and business.

**Travel Estimate**

Need based

**Job Scope**

**Internal Interactions (within the organization)**

Plant Management, Business Users, Corporate IT Teams, Quality and CSV Teams

**External Interactions (outside the organization)**

Various Service providers, Vendors, Customers, Regulatory Auditors.

**Geographical Scope**

To Support Guwahati, at the same time provide onsite / offsite support to other site whenever needed.

**Financial Accountability (cost/revenue with exclusive authority)**

Based on Approved Budgets for the sites - Both Opex & Capex

**Job Requirements**

**Educational Qualification**

BE/B. Tech, MCA, BCA, MSc IT, BSc. IT, Graduation + PGDCA.

**Specific Certification**

NA

**Skills**

IT Infrastructure Management, CSV Support, IT regulatory requirements, Quality Informatics and Manufacturing Informatics.

**Experience**

6 - 8 Years in IT Operations, Preferably in Pharma Manufacturing.