Full description

**Sr. No.Job Responsibilities

To
prepare and review central guidance/policies/SOPs for computerized system

To
prepare validation plan, Validation summary report and System release
certificate of centralized GxP software

To
review and approve software validation deliverables of centralized GxP
software

To
review change controls, Deviation and CAPA of centralized GxP software

To
carryout software supplier assessment for centralized GxP software

To
coordinate and conduct training programs and workshop (internal and external)
on current cGMP trend, central quality policy, standard practice and
directive as and when required.

To
perform review of computerized systems document with respect to established
procedures and current regulatory requirements to assist site user for
compliance

To
ensure shop floor IT compliances at sites such as compliance of IT Standard
Operating Procedure, User Access Management, Data center Qualification and
Network Qualification.

To
perform onsite verification of Global CAPA/ Informatics/Quality Intelligence
points for computerized system

To
Provide support to the sites for Regulatory Audit preparation

To
Providing resolution for queries related to computerized system

To
proactively identify emerging cGMP requirement with respect to computerized
system and implementation as and when required.

To
perform gap assessment related to Computerized system with respect to
regulatory guideline, US FDA 483 form, USFDA warning letter

Preparation
of informatics status reports for the management as and when required.