IPQA-API/Biosimilar

3 - 8 years

5 - 8 Lacs

Posted:18 hours ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

  • Ensure

    cGMP compliance

    during manufacturing operations
  • Perform

    line clearance

    and in-process checks
  • Review

    BMR/BPR

    , logbooks, and manufacturing documents
  • Monitor

    critical process parameters (CPPs)

    on shop floor
  • Initiate, investigate, and close

    deviations

  • Prepare and follow up

    CAPA

  • Support

    change control

    and risk assessments
  • Ensure compliance with

    SOPs, GDP, and data integrity (ALCOA+)

  • Participate in

    internal audits and regulatory inspections

  • Coordinate with Production, QC, and Engineering teams

Preferred candidate profile

  • Strong knowledge of

    cGMP / GMP guidelines

  • Exposure to

    USFDA / EU-GMP / WHO

    regulations
  • Experience in

    BMR/BPR review & issuance

  • Deviation, CAPA, change control handling
  • Good understanding of

    QMS

  • Shop-floor exposure and documentation skills

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MJ Biopharm logo
MJ Biopharm

Biopharmaceuticals

Boston

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