Assistant Manager

Role & responsibilities

1. Handling QC and IT Projects like (QMS, Empower Software, Standalone Applications, etc.,).

2. Handling Internal and external Auditors like (USFDA, ANVISA, Client audits, etc.,).

3. Coordinate, handle, and manage Internal/External audits, certification audits, or inspections and ensure accuracy and availability of information during these audits.

4. Maintaining compliance with regulatory requirements across locations.

5. Computer System Validation for GxP Computers and Servers across locations.

6. To diagnose computer problems, monitor performance, perform tests on computer equipment and programs, install software, and schedule maintenance.

7. Good knowledge of backup & restoration mechanisms and exposure to any data backup software application

8. Managing IT Service desk, including SLA reports

9. Hands-on with installing Windows 11 desktop OS, Windows Server OS, Databases with Upgrades & patch updates

10. Understanding of the basics of different types of networks with various active & passive components

11. Knowledge & Exposure to installing & managing various endpoint security solutions like CrowdStrike, Trellix, Defender, etc.

12. Knowledge of various types of Cloud & exposure to any cloud-based application, like O365, etc.

13. Coordinate with central IT to resolve various issues.

14. Perform a Systems Audit Trail review for GxP Computerized systems and servers.

15. Handling Quality Management Systems (Change Controls, Deviation, Risk assessments, Impact assessments, CAPA and Investigations, etc.) related to IT.

16. Conducting in-house audits in the IT department and ensuring that locations -the IT department fully complies with GxP.

17. Conduct review meetings and report them on time.

18. Enhance technical skills by participating in seminars, workshops, free online courses, technical courses, etc.

Additionally responsible for carrying out any works assigned or delegated by the Head/ Designee.

Preferred candidate profile

Educational Qualification

Experience