Backup & QA Analyst

Indussystem; Mumbai; On-site; INR 600,000 - 800,000; Full time

Job summary

INDUS Systems in Mumbai is seeking a Pharma IT documentation specialist to manage change control, track action plans in a TrakWise system, and prepare SOPs. The role involves quality management system work, deviation tracking, CAPA activities, audit support, and creating investigation reports, root cause analyses, and related documentation.

You will also handle Commvault backup configuration, server and endpoint recovery procedures, logbook maintenance, and daily/weekly/monthly backup reports;

Qualifications

• Pharma IT background mandatory.
• Should be ready to work in shifts.
• Experience on GxP systems, Pharma audits, documentation.

Responsibilities

• Handle documentation in TrakWise and action plan tracking.
• Prepare IOPQ Server qualification and Network qualification documentation.
• Prepare and implement IT SOPs and support QA audits.
• Maintain QMS documentation and CAPA processes.
• Manage Commvault backup configurations and monitoring.
• Daily/Weekly/Monthly backup monitoring and reporting.
• Logbook maintenance and error history tracking.

Skills

Pharma IT background

Communication skills

GxP/documentation experience

Tools

TrakWise

Commvault

EM Signer

Job description

As processes are becoming more complex, competitive and demanding, businesses are constantly exploring new ways to deploy effective solutions. We at INDUS Systems, over the years, have synchronised our team to offer best-of-breed solutions from leading technology partners coupled with our Professional Services to help customers protect their IT investments, reduce costs and grow their businesses. Our IT Solutions increase people efficiency, reduces infrastructure footprint which acts as a catalyst towards quantum business growth. We thrive to be a hand-holding partner in customer's journey.

Job Description

Below is JD:

Handling Documentation as follows:

• Raising Changerequest and action plan in a Trak wise system.
• Change requestClose out after completion of task as per the action plan and trackability ofaction plan.
• IOPQ Serverqualification and Network qualification documentation preparation.
• IT Standardoperation procedure (SOP) preparation and implementation.
• Audit supportfor IT related compilation and support.
• IT documents andBound book reconciliation with QA department and excel sheet maintenance.
• Justificationfor FMECA

Qualitymanagement system (QMS) preparation and handling as below.

• Raising Deviation in Track wise system
• CFT Meeting arrangements
• Investigation report preparation
• Smart Root cous Analysis
• 5 Why analysis, Faulty tree and fish bone
• Rubric
• Training reports and person interviews.
• CAPA
• After deviation closer CAPAtrackability and CAPA implementation
• CAPA effectiveness check
• Responsiblefor handling Commvault Backup as follow:

• Clientconfiguration (Server and Endpoint) with Commvault.
• Backupconfiguration with Commvault (Application, File system, Virtual).
• Restoration ofbackup (Application, File system, Virtual).
• Assign A, B, C,D Weekly and Monthly Media Tape in Autoloader.
• Media managementand Storage in Fireproof cabinet at Security Gate unit Extension.
• Daily backup Jobmonitoring
• Backupvalidation of all PTG site applications.
• Backupvalidation schedule preparation of all applicable departments.
• Logbookmonitoring and maintained.
• Making entry inError History log failed client and server.
• Resolve thefailed 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

• Pharmabackground in IT is mandatory.
  
• Shouldbe ready to work in shifts.
  
• Shouldhave work experience on GxP systems, Pharma audits, Documentations.
  
• Shouldhave strong communication skills to handle audits.