Sme Gxp Operations

3 days ago

Bengaluru, Karnataka, India Syngene International Full time

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

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