Associate Manager - CQ - Informatics

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.