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:

· 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.

Habilidades requeridas

TrackWise change control (raise/close change requests, action plans)SOP development and implementation (IT Standard Operating Procedures)Qualification documentation (IOPQ, Design Qualification, URS)GxP / Pharma IT compliance knowledgeAudit support and audit communication (pharma audits)Quality Management System (QMS) operation including deviation handling and CAPA managementRoot cause analysis techniques (5 Whys, fishbone, fault tree, Smart RCA)FMECA/FMEA analysis and RPN scoringCommvault (CommCell) backup administrationBackup configuration and restoration for applications, file systems and virtual environmentsMedia and tape management (autoloader assignment, tape storage, media handling)Backup monitoring, validation and reporting (job monitoring, validation schedules, EM signer reports)Documentation reconciliation and records management (bound books, Excel, logbooks)Risk communication and stakeholder coordination

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