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    Job · 18503899

    Uteshiya Medicare logo

    Walk-in || Qa Executive

    Uteshiya Medicare · Ahmedabad · onsite · Posted 33d ago

    ₹2.5L - ₹3.5L PA0–2 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    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.

    Sourced from naukri

    Skills

    IPQABmrGMPQuality Assurance

    Walk-in || Qa Executive · waiting for your command