Specialist - QA (Batch Release)

Job summary:

• 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.
• Bachelor / Master degree in pharmacy
• Experience minimum 4 Years