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.
