Job Summary

Responsibilities

- Raising Change request and action plan in a Trak wise system.

- Change request Close out after completion of task as per the action plan and trackability of action plan.

- IOPQ Server qualification and Network qualification documentation preparation.

- IT Standard operation procedure (SOP) preparation and implementation.

- Audit support for IT related compilation and support.

- IT documents and Bound book reconciliation with QA department and excel sheet maintenance.

- Current project related documentation preparation, execution, technical support and project finalization as below. Impact assessment URS Design qualification IOPQ qualification FMECA (calculation and RPN scoring).

- FMECA CFT document.

- Justification for FMECA.

- Risk communication.

- Quality management system QMS preparation and handling as below.

Raising

Deviation in Track wise system CFT Meeting arrangements Investigation report preparation Smart Root cause Analysis 5 Why analysis, Faulty tree and fish bone Rubric Training reports and person interviews. CAPA.

- CAPA after deviation closer CAPA trackability and CAPA implementation.

- CAPA effectiveness check.

- Responsible for handling Commvault Backup as follow.

- CommCell Environment Overview.

- Client configuration (Server and Endpoint) with Commvault.

- Backup configuration with Commvault (Application,



File system, Virtual).

- Restoration of backup (Application, File system, Virtual).

- Media Management.

- Assign A, B, C, D Weekly and Monthly Media Tape in Autoloader.

- Media management and Storage in Fireproof cabinet at Security Gate unit Extension.

- Daily backup Job monitoring.

- Backup validation of all PTG site applications.

- Backup validation schedule preparation of all applicable departments.

- Logbook monitoring and maintained.

- Making entry in Error History log failed client and server.

- Resolve the failed backup client and servers.

- Daily, Weekly, monthly and yearly Backup report signs out through EM signer application, client Disk, client Tape Out, server Disk and Server Tape Out.

Requirements

- Pharma background in IT is mandatory.

- Should be ready to work in shifts.

- Should have work experience on GxP systems, Pharma audits, Documentations.

- Should have strong communication skills to handle audits.

Experience

5+ years

Job Type

Full time

Location

Maharashtra, India

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📌 Backup & QA Analyst (Mumbai)
🏢 Indus Systems
📍 Mumbai