Senior Officer - API

Responsible for review and closure of Executed Batch record and ECRs.

Responsible for review of Master batch record, Process flow diagram, Process development report and ECRs.

Responsible for Preparation of APQR & PPQR.

Responsible for Batch release of Intermediates & APIs.

Responsible for monitoring of online activities in manufacturing area.

Responsible for equipment clearance/product changeover line clearance activity.

Responsible for of dispensing activities for raw material, Intermediate.

Responsible for monitoring of sampling activities for Intermediates and APIs.

Responsible for monitoring the packing activities of APIs and Intermediates.

Responsible & Management of Retention Sample activity.

Responsible for review and approval of analytical data for Raw Materials and Packing materials.

Responsible for issuance, distribution and retrieval of logbooks,

Master batch record, Equipment cleaning record, formats and other document