Title:  Executive

Name:

Replacement of Naveen Kumar Singh

Employee id:

366110

Job Title:

Executive – IT

Job Grade:

G12A

Function:

Global InfoTech

Sub-function:

Quality IT Support

Manager’s Job Title:

Manager II - IT

Skip Level Manager’s Title:

Sr. Manager I - IT

Function Head Title:

CIO

Location:

Guwahati

No. of Direct Reports (if any)

NA

Date of Joining:

As earliest possible

Job Summary

The Job holder will be responsible to support Quality Control labs Systems at Guwahati. Responsible for Inventory Management, 21CFR Part 11 Assessment, Qualification & Validation of Quality Control labs 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, 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 Quality Control labs Systems including. 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 Quality Control labs System including installed at site.
• 21 CFR Part 11 Assessment and Implementation.
• Prepare and maintain IT related SOPs (as applicable) for Quality Control labs Systems.
• Perform / participate into qualification and validation of Quality Control labs Systems from IT for various IT Admin roles.
• Review of qualification and validation documents of Quality Control labs 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 Quality Control labs Systems as per applicable SOP(s) at site.

• Participate in internal and external Audits to respond on IT related points for Quality Control labs Systems
• Review & verification of Corrective Action Plan identified for Quality Control labs 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

5-6 Years in IT Operations, Preferably in Pharma.

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).