Executive/ Senior Executive- IPQA- DS - Pune District - Enzene Biosciences Ltd

    Enzene Biosciences Ltd
    Enzene Biosciences Ltd Pune District

    3 days ago

    Description

    Job Title: Executive / Senior Executive – QA (DSQA)

    Department: Quality Assurance

    Location: Pune

    Experience: 2–9 Years

    Qualification: M.Sc / M.Pharm

    Job Purpose

    To ensure cGMP compliance at the shop floor for Drug Substance (DS) manufacturing through effective line clearance, documentation review, in-process oversight, and quality systems activities.

    Key Responsibilities

    • Perform manufacturing line clearance on the shop floor for DS activities.
    • Ensure proper execution and compliance of in-process checks during manufacturing operations.
    • Conduct routine GMP rounds at the Drug Substance facility and document observations.
    • Review online batch manufacturing records (BMR) for accuracy, completeness, and compliance.
    • Review and approve process validation protocols and reports, cleaning validation protocols and reports.
    • Review and manage Standard Operating Procedures (SOPs) and other protocols/reports related to shop floor operations.
    • Coordinate collection and submission of samples as per BMR, specifications, process validation, and stability protocols.
    • Perform regular shop floor compliance rounds to ensure adherence to cGMP and follow up on corrective actions.
    • Prepare and support Annual Product Quality Review (APQR/PQR) documents.
    • Initiate and manage Change Control, Deviations, Incidents, and CAPA, including investigation support and timely closure.
    • Participate in QMS investigations and root cause analysis.
    • Ensure continuous cGMP compliance and regulatory readiness at the shop floor.
    • Perform risk assessments for critical manufacturing and quality processes.

    Skills & Competencies

    • Strong knowledge of cGMP, QMS, and regulatory requirements
    • Hands-on experience with DS/DP shop floor QA activities
    • Understanding of process validation, cleaning validation, and in-process controls
    • Experience in BMR review and documentation control
    • Good analytical, investigation, and problem-solving skills
    • Effective communication and coordination with cross-functional teams

    Regulatory Exposure

    • USFDA, EMA, WHO, and other global regulatory guidelines (preferred)
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