QA Batch Release

About the role

To assure Quality of products with ontime BMR review and release with 100% compliance.

Key responsibilities

• Review of production schedule and their compliance to the specific requirements in the manufacturing of products
• Ensure correct and timely issuance of batch documents
• Review the completed batch documents and ensure compliance to the manufacturing process before the batch is released
• Ensure timely review and release of batch manufacturing record as per GDP
• Ensure traceability and reconciliation of all documents and review the same for non-compliance
• Ensure proper storage of all the Batch manufacturing record in a systematic manner for easy and quick retrieval
• Maintenance and Destruction of documents after its expiry period with proper record as per SOP
• Support to QA Lead during the internal and external audits
• Perform Usage Decision of batch in absence of QA Lead
• Ensure the Plant complies to the QMS system as per the laid down guidelines

About you

• Bachelor's Degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related field
• Direct experience in QA Batch Release and Batch Manufacturing Record (BMR) review
• Knowledge of cGMP, GDP, Data Integrity, and QMS standards
• Adherence to Regulatory Compliance and GMP/Process Audits
• Ability to perform Usage Decision (UD) and handle batch release requirements
• High attention to detail and good cross-functional communication skills