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    Job · 12747871

    Shilpa Medicare logo

    Walk-ins For Quality Control (QC) & QA(QMS) - Formulations

    Shilpa Medicare · Hyderabad · onsite · Posted 62d ago

    Undisclosed2–6 yrsfulltimeSourced fromNaukri

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

    About this role

    Role & responsibilities

    for Analytical services- QC


    Execute analytical method validation and monitor validation parameters in compliance with ICH and ANVISA guidelines.

    Prepare and review method validation protocols, raw data, and validation reports.

    Perform and review formulation finished product analysis for both oral and injectable products in line with regulatory requirements.

    Handle analytical instruments including HPLC, GC, FTIR, UV-Visible spectrophotometer, and water content determination by Karl Fischer.

    Review analytical data and ensure compliance with approved specifications, procedures, GMP, and regulatory requirements.

    Support OOS, OOT, deviation, and related analytical investigations..


    FOR QA- QMS


    Review chromatograms, raw data, audit trails, and analytical reports for GMP compliance.

    Support OOS, OOT, deviation, and laboratory investigations.

    Ensure compliance with ALCOA+ data integrity principles.

    Manage Deviations, Change Controls, CAPAs, Risk Assessments, and Investigations.

    Monitor QMS metrics and prepare quality trend reports.

    Support internal, customer, and regulatory audits.

    Ensure QMS compliance and continuous quality improvement.

    Handle Computer System Validation (CSV) and qualification activities.

    Monitor LIMS data, chromatographic systems, and stability chamber performance to ensure accuracy, compliance, and quality standards.

    Preferred Candidate Profile

    Hands-on experience in Quality Assurance / QMS activities in the pharmaceutical industry.

    Strong knowledge of GMP, ALCOA+, data integrity, investigations, CAPA, change control, and audit requirements.

    Good documentation, review, coordination, and analytical data assessment skills.





    Preferred candidate profile


    Male candidate preferred

    Perks and benefits



    Sourced from naukri

    Skills

    OSDootStabilityAnalytical Method ValidationMethod TransferDocumentiondeviationfinished productsCAPAoosMethod DevelopmentMethod ValidationStability StudiesHPLCGCanalytical quality assuranceQMSQuality AssuranceQuality ControlanalyticalQCFormulation

    About Shilpa Medicare

    Shilpa Medicare logo

    Shilpa Medicare

    Pharma

    2.4k+

    employees

    1987

    39 years old

    Raichur, Karnataka

    India

    ₹6.2L PA avg

    Avg at Shilpa Medicare

    About

    Shilpa Medicare specializes in oncology products, providing APIs and formulations while expanding into novel drug delivery systems and biotech.

    Industries

    Pharma

    Employee ratings

    10 reviews

    3.5/ 5

    Culture

    2.9

    Career growth

    3.1

    Work-life

    3.7

    Employees rate it well for

    Overall Company35Work-Life Balance34

    Find them on

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    Walk-ins For Quality Control (QC) & QA(QMS) - Formulations · waiting for your command