Monitoring of IPQA activities Granulation, Compression, Coating, Capsule Filling, soft gel manufacturing, primary and Secondary Packaging Area.
Monitoring Exhibit and Validation batches.
Preparation and review of process validation and Hold time protocols and reports.
Handling of Quality Notifications like Deviations, Change Controls, and its related Documents.
Reviews and Approval of CAPA includes tracking, follow-up, reporting/trending and evaluating CAPA and action plan for effectiveness.
Review of APQR (Annual Product Quality Review) based on the outcome CAPA shall be initiated.
Ensure performance of self-Inspection/ Internal audits (Internal, External, Customer, Visits, and Regulatory) and assist with external quality system audits.
Providing response for Manufacturing related regulatory audit observations.
Qualification & Experience
12-15 years in Quality Assurance specifically in IPQA
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