Pranali Patel

Quality Assurance Specialist

Role
Quality Assurance Specialist (Batch Record Review & Release) at Lupin Pharmaceuticals
Location
Edison, NJ, US
LinkedIn followers
500 followers

About Pranali Patel

Quality Assurance Specialist with a diversified experience in Quality Control Department…

Experience

  1. Quality Assurance Specialist (Batch Record Review & Release)

    Lupin Pharmaceuticals

    Mar 2026 — Present · Somerset, NJ, US

    Quality Assurance Specialist in GMP manufacturing with expanded responsibilities including batch record review and release authority. Lead end-to-end documentation, SOP management, and compliance for production and quality systems- Led batch record end-to-end: Issued, reconciled, assigned expiry, reviewed, and authorized release for all Production/Packaging batches, ensuring cGMP compliance and quality decisions- Executed batch review & release: Verified data integrity, compiled released/rejected batches, prepared COA reports from QC results- Oversaw document lifecycle: retention, storage, destruction (including Quality Alerts), and archival- Managed full SOP lifecycle: Wrote/reviewed/updated SOPs; handled numbering, approval, distribution, training, and control- Controlled notebooks, logbooks, preventive maintenance forms; supported Master Control system- Applied quality process knowledge: material handling, change control, deviations, CAPA; supported all GMP functions.

Education

  • Navrachana University

    Bachelor of Science - BS

    2015 — 2018

  • Navrachana University

    Master of Science - MS

    2018 — 2020

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Pranali Patel — Quality Assurance Specialist (Batch Record Review & Release) at Lupin Pharmaceuticals in Edison, NJ, US | Unifers