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
Setting 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.

📌 Backup & QA Analyst (Mumbai)
🏢 Important Company of the Sector
📍 Mumbai