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    Job · 18417662

    Utkarsh Placement logo

    Qa Executive

    Utkarsh Placement · Mohali · onsite · Posted 32d ago

    Undisclosed2–5 yrsfulltimeSourced fromNaukri

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

    About this role

    Job Description QA Executive /QA Officer/ Sr. QA Officer


    Location: Dera Bassi, Punjab
    Department: Quality Assurance
    Industry: Pharmaceutical API Manufacturing
    Experience: 3–5 years in API Quality Assurance
    Qualification: B.Pharm / M.Pharm / B.Sc. / M.Sc.

    Key Responsibilities

    • Prepare, review, revise and control QA documents as per cGMP and regulatory requirements.
    • Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), logbooks and analytical documentation.
    • Handle deviations, incidents, CAPA, change controls and root-cause investigations.
    • Prepare and revise SOPs, formats, protocols and other quality-system documents.
    • Manage document issuance, retrieval, archival, version control and record retention.
    • Conduct shop-floor monitoring, line clearance and in-process compliance checks.
    • Support equipment qualification, process validation and cleaning-validation activities.
    • Review calibration, preventive-maintenance and qualification records.
    • Ensure compliance with data-integrity requirements and ALCOA+ principles.
    • Participate in internal, customer and regulatory audits and support closure of audit observations.
    • Coordinate with Production, QC, Warehouse and Engineering departments on quality-related matters.
    • Conduct or coordinate cGMP and SOP training and maintain training records.
    • Ensure timely completion and closure of all assigned quality-system activities.

    Candidate Profile

    • Must have 3–5 years of QA experience in an API manufacturing facility.
    • Strong knowledge of cGMP documentation and pharmaceutical quality systems.
    • Hands-on experience with deviations, CAPA, change controls, investigations and batch-record review.
    • Familiarity with regulatory standards such as WHO-GMP, ICH, USFDA or EU-GMP.
    • Good documentation, communication and cross-functional coordination skills.

    Please share me your updated resume at: [email removed]

    Sourced from naukri

    Skills

    QAAPI ManufacturingCGMPBulk DrugsQA AuditQuality AssuranceDocumentationActive Pharmaceutical Ingredient

    About Utkarsh Placement

    Utkarsh Placement logo

    Utkarsh Placement

    Recruitment

    25

    employees

    1994

    32 years old

    Vadodara

    India

    ₹4L PA avg

    Avg at Utkarsh Placement

    About

    Utkarsh Placement Pvt. Ltd specializes in recruitment consulting, primarily serving the manufacturing sector across India since 1994.

    Industries

    EmploymentHuman ResourcesRecruitingStaffing Agency

    Employee ratings

    10 reviews

    3.5/ 5

    Culture

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    Career growth

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    Work-life

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    Qa Executive · waiting for your command