Job Description

Core Purpose of the Role:IT Operations SME manages the QC & Mfg. Systems at Syngene and provide operational supports for computerized systems. Knowledge of current regulatory & Guidelines 21 CFR Part 11 ERES, EU Annex 11 and SOP requirements of computerized systems w.r.t. data security, traceability, and integrity.Key Responsibilities:

• Act as administrators in Instrument/Equipment connected application software in GxP Systems.
• Responsible for Privileges & User Management (User Creation, Modification, Enable/Disable, Lock/Unlock, etc.) as per SOP for the GxP computerized systems.,
• Responsible for Data Backup/Restore Management for Computerized Systems.
• Responsible for performing the data restore on users\' requests/periodically, verify it along with users, and maintain their activities logs in line to SOP requirements.
• Responsible for System Configuration & Security Policies Implementation and for ensuring system is in compliant state.
• Responsible for verification and correction of date & time on Lab instruments and standalone GxP computer systems.
• Responsible for performing the changes in instruments/equipment connected applications software in GxP computerized systems as per change management procedure.
• Responsible for completing/implementing the site\'s IT-related Change Controls, Deviations, Investigation Reports, CAPAs, and Audit Observations, if any.
• Responsible for executing computer systems qualification and validation (CSV) activities in GxP systems as per Computer Systems Validation requirements.
• Responsible for facing the internal/regulatory audits and will be able to demonstrate the required compliance & controls are in place w.r.t. IT systems administrations, Operations, data backup/restore, security, traceability, and integrity to the auditors on demand.
• Liaison with IT Infra team and vendors for technical support/escalations w.r.t. Operating Systems (OS), instrument/equipment connected application software, data backups & restore.

Technical and Leadership skills:

• Knowledge on data backup, restore for GxP instruments.
• Knowledge on Administration of Quality Control systems such as Chromeleon, Empower LIMS, KF-Auto Titrator spectrophotometer, LC/MS, HPLCs, GCs, NMR, FT-IR, pH-Meter etc.
• Knowledge on GxP QC Systems - Administration, Security Policies & Configuration, Privileges & User Roles Management, Audit Trail Review, Date & Time Setting, and User Management (such as User Creation, Modify, Activate, Deactivate, Disable, Enable, Role assignment etc.); and maintaining their records as per SOP.

Qualification & Experience:Graduation or Post graduation in Engineering or relevant fields + working experience in Pharmaceutical / Life science

Syngene International