Jobs for People with MS: National MS Society

Job Title:

Executive MI Support

Job Grade:

G12A

Function:

Global InfoTech

Sub-function:

Manufacturing IT Support

Location:

Guwahati

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.

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.