Specialist - Batch Release

Detailed Job Description

• 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 reviewing Batch Documents as per the related checklist of the SOP QA-00-009
• Responsible for checking the details of vendors 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
• Responsible 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 perform QMS actions.
• Perform any other work assigned by the Team Leader/ QA Manager.
  
  

• Must be able to manage tasks and priorities and easily adapt to changing situations
• Flexible learning abilities
• Responsible and Accountable
• Able to handle complexity at system level/ tasks level
  
  

• Advanced knowledge in cGMP
• Proven understanding and well-disciplined while dealing with all stakeholders.
• Excellent knowledge of reporting procedures and record keeping.
• Bachelor’s degree in pharmacy
• 2-4 years of experience