Job Description

Department DetailsRole Summary

• Maintain inventory list of Scientific and QC applications at Site.
• Assist in 21 CFR Part 11 Assessment during Computerized system selection.
• Prepare and Maintain IT related SOPs (as applicable) for QC and Scientific automated

systems.

• Perform/participated into qualification and validation of IT Applications for various IT admin

roles.

• Provide IT administrative support on Operating Systems (OS) of Computer Servers, Desktops,

Laptops, Industrial PCs, and Handheld devices etc., which are used at Site.
For example:
o User Management (Creation, Modification, Password reset etc.).
o User Access Rights Management on various drives, files and folders.
o Date and time Management.
o OS Policy Management.
o Backup & Restoration Management.
o Installation/ upgradation of Operating System, OS Service Pack/ Patch Management.
o Antivirus Management (if applicable).
o Periodic review of event logs (as where applicable).
o Provide support to vendor/OEM for fixing IT related issues during breakdowns.

• Perform the data and program backup and retrieval of Scientific Systems as per application

SOP(s) at Site.

• Review and verification of corrective Action plan identified in all Scientific and QC

applications during internal and external audits.

• Preparation and Execution of IT SOPs, Change Control, Deviation and CAPA
• Data export from OT systems and making it available for cross functional user\'s process

related analysis.

• Initiation of QMS as per IT Operation requirements, investigation, CAPA implementation.
• Preparation of SOPs as per process development requirements for Information technology

Key Responsibilities

• Maintain inventory list of Scientific and QC applications at Site.
• Assist in 21 CFR Part 11 Assessment during Computerized system selection.
• Prepare and Maintain IT related SOPs (as applicable) for QC and Scientific automated

systems.

• Perform/participated into qualification and validation of IT Applications for various IT admin

roles.

• Provide IT administrative support on Operating Systems (OS) of Computer Servers, Desktops,

Laptops, Industrial PCs, and Handheld devices etc., which are used at Site.
For example:
o User Management (Creation, Modification, Password reset etc.).
o User Access Rights Management on various drives, files and folders.
o Date and time Management.
o OS Policy Management.
o Backup & Restoration Management.
o Installation/ upgradation of Operating System, OS Service Pack/ Patch Management.
o Antivirus Management (if applicable).
o Periodic review of event logs (as where applicable).
o Provide support to vendor/OEM for fixing IT related issues during breakdowns.

• Perform the data and program backup and retrieval of Scientific Systems as per application

SOP(s) at Site.

• Review and verification of corrective Action plan identified in all Scientific and QC

applications during internal and external audits.

• Preparation and Execution of IT SOPs, Change Control, Deviation and CAPA
• Data export from OT systems and making it available for cross functional user\'s process

related analysis.

• Initiation of QMS as per IT Operation requirements, investigation, CAPA implementation.
• Preparation of SOPs as per process development requirements for Information technology

Educational QualificationsRequired Education Qualification:
Required Experience: 7 - 9 years

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