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Quality Control Manager

Ephicacy

Mumbai

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2 w

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Full time

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Healthcare

Minimum

$1,200,000 Per Year

Maximum

$2,800,000 Per Year

Leads quality control laboratory operations across raw material, in-process, and finished goods. Manages a team of QC analysts, scientists, and laboratory technicians. Oversees method development, validation, and transfer for all analytical methods. Ensures laboratory equipment qualification, calibration, and maintenance programs. Reviews and approves analytical data, QC release, and stability protocols. Manages OOS/OOT investigations and ensures timely resolution. Leads laboratory audit readiness and manages responses to inspector observations. Oversees reference standard management and reagent control programs. Ensures LIMS system integrity and data integrity compliance across laboratory. Manages stability study programs and prepares annual stability reports. Coordinates with production, QA, and procurement teams on quality matters. Prepares QC section for regulatory submissions and product dossiers. Stays current with USP, BP, ICH Q2R1, and regulatory data integrity guidance.