Walk-in | Qa Executive

Uteshiya Medicare; Ahmedabad District; On-site; INR 600,000 - 750,000; Full time

Job summary

Uteshiya Medicare is seeking a documentation professional to review Batch Manufacturing Records (BMRs) for completeness and compliance, ensure proper sign-offs, and maintain traceability of manufacturing documents. You will coordinate with Production, Quality, and Engineering to close documentation gaps and support audits and continuous improvement initiatives.

The role emphasizes adherence to SOPs, timely BMR release, and active participation in knowledge transfer during transitions within the

Responsibilities

• Review Batch Manufacturing Records (BMRs) thoroughly for completeness, accuracy, and compliance.
• Check manufacturing records against approved SOPs, specifications, work instructions, and quality requirements.
• Ensure all required entries, signatures, approvals, and supporting documents are properly completed.
• Identify documentation errors, missing information, deviations, or discrepancies and coordinate with the concerned teams for closure.
• Maintain proper control and traceability of manufacturing and quality-related documents.
• Ensure timely BMR review and release to avoid delays in manufacturing and product dispatch.
• Coordinate with Production, Quality, Engineering, and other relevant departments on documentation-related issues.
• Follow all applicable SOPs and ensure proper documentation practices are maintained.
• Support internal audits, documentation reviews, and compliance-related activities when required.
• Contribute to improving the BMR review and release process and reducing documentation-related delays.
• Support the team during the upcoming transition by participating in proper knowledge transfer and handover activities.

Job description

Responsibility

• Review Batch Manufacturing Records (BMRs) thoroughly for completeness, accuracy, and compliance.
• Check manufacturing records against approved SOPs, specifications, work instructions, and quality requirements.
• Ensure all required entries, signatures, approvals, and supporting documents are properly completed.
• Identify documentation errors, missing information, deviations, or discrepancies and coordinate with the concerned teams for closure.
• Maintain proper control and traceability of manufacturing and quality-related documents.
• Ensure timely BMR review and release to avoid delays in manufacturing and product dispatch.
• Coordinate with Production, Quality, Engineering, and other relevant departments on documentation-related issues.
• Follow all applicable SOPs and ensure proper documentation practices are maintained.
• Support internal audits, documentation reviews, and compliance-related activities when required.
• Contribute to improving the BMR review and release process and reducing documentation-related delays.
• Support the team during the upcoming transition by participating in proper knowledge transfer and handover activities.

Authority

• Review and verify Batch Manufacturing Records (BMRs) for completeness, accuracy, and compliance with approved SOPs and quality requirements.
• Raise queries or observations on incomplete, incorrect, or non-compliant documentation and coordinate with the concerned department for resolution.
• Hold or recommend withholding BMR release where required documentation, approvals, or compliance requirements are not adequately fulfilled.
• Coordinate with Production, Quality, Engineering, and other relevant departments to ensure timely closure of documentation-related issues.
• Recommend BMR release after confirming that all required documentation and compliance checks have been satisfactorily completed.
• Escalate critical documentation gaps, deviations, or recurring issues to the appropriate QA authority for further action.
• Maintain confidentiality, integrity, and traceability of all manufacturing and quality-related records.
• Exercise authority within the limits defined by applicable SOPs, quality systems, and organizational policies.