Executive-IPQA [General Injectable-Packing]

Involved in eBMR & eLogbook software installation to implement paperless manufacturing process.

Working with greenfield project to develop IPQA & Validation relevant documents, team and acquire essential items for execution.

To monitor & participate in qualification activities of Utilities/Facility/Equipment etc. if

required.

Responsible for monitor, verification, preparation, review, approval of IPQA activities,

The manufacturing process for yield reconciliation, Annual Product Review, Change control, Deviation, Investigation, CAPA, OOS, SOP, Risk assessment and other QMS documents as applicable.

Responsible for Review and approval of Master BMR / BPR executed BMR / BPR and finished product release.

To support validation plans for process validations/ cleaning validation and to support in review & approval of all validation documents and related activities.

To participate as an auditor for approval of RM/PM vendors and contract manufacturers.

To part of Cross-functional team for Investigation of Market complaints, Incidence happening on Shop-floor and Represent the company during external inspections