Below is JD:

Handling Documentation as follows:

· 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.

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

· FMECA CFT document

· Justification for FMECA

· Risk communication

· Quality management system (QMS) preparation and handling as below. Ø Raising Deviation in Track wise system Ø CFT Meeting arrangements Ø Investigation report preparation Ø Smart Root cous Analysis Ø 5 Why analysis, Faulty tree and fish bone Ø Rubric Ø Training reports and person interviews.



Ø CAPA Ø After deviation closer CAPA trackability and CAPA implementation Ø CAPA effectiveness check Ø Responsible for handling Commvault Backup as follow:

· Comm Cell 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 robust communication skills to handle audits.

📌 Backup & QA Analyst (India)
🏢 Indus Systems & Services
📍 India