20 Sep
|
Uteshiya Medicare
|
Ahmedabad
20 Sep
Uteshiya Medicare
Ahmedabad
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.
📌 Walk-in || Qa Executive (Ahmedabad)
🏢 Uteshiya Medicare
📍 Ahmedabad