• Citizen

• Full Time

• Direct Hire

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 24th Aug 2022

Roles and Responsibilities

Review of BMR/ BPR received from CMO sites. Preparation of quality agreements, must have excellent communication skills, coordinate with CMO sites for support.

Initiation, review and tracking of QAMS element, like, deviation, change control, CAPA market complaint,

Participation and review of failure investigation, investigation related to market complaint, deviation etc.

Preparation and review of Quality Risk Management.

Preparation review and implementation of QA SOP, Review, evaluation and implementation of CQA SOP.

Prepare and review of APQR.

Ensure the manufacturing activities are being carried out as per the approved procedure and incompliance with the cGMP.

Review of executed Batch Processing Records, Process Validation, cleaning validation documents.

Preparation, review and apporval of master documents like study protocol, BPR, MFR etc.

Handling of batch released activities.