To adhere with the cGMP principles and to ensure effective measures taken for Good Documentation practices in Batch Documents.
Responsible to perform Batch Document Review for all dosage form related to all departments (Production, Packaging, Q.C., Store, and Eng.) and to ensure timely completion of document review activity.
Responsible for reviewing and auditing all completed Batch records at all process stages for all dosage forms & to ensure the conformance as per the requirement of cGMP and related SOP’s
Responsible for review of Batch Documents as per the related checklist of the SOP TCS-003.
Responsible to check the details of vendor used in the batch as per Approved vendor list.
Responsible to update the daily tracker for the observations identified and follow up with related departments for corrections in Manufacturing/Packaging documents.
Responsible to ensure any deviations/investigations occurred in the batch & documented the deviation/investigation details prior to entry of batch record compliance in SAP
Resposnsible to provide the details of batches entered in SAP as a part of compliance at the end of the day for final release
Responsible to issue the batch release certificate for final batch approval.
Responsible to prerform QMS actions.
Perform any other work assigned by the Team Leader/ QA Manager.
Core Competencies:
Must be able to manage tasks and priorities and easily adapt to changing situations
Flexible learning abilities
Responsible and Accountable
Good experience in sterile manufacturing
Able to handle complexity at system level/ tasks level
Qualification/Functional knowledge:
Advanced knowledge in cGMP
Proven understanding and well-disciplined while dealing with all stakeholders.
Excellent knowledge of documents control, review and archiving.
