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Job description

• To conduct new vendor audits, requalification/routine audits, for-cause/risk-based audits for vendors manufacturing and supplying Primary and printed Packaging materials for Glenmark products. • To review audit compliance reports and ensure the implementation of agreed CAPA at vendor end • To review and maintain vendor qualification documents. • To evaluate the Change controls for a new/alternate vendor introduction or for changes endorsed in view of vendor notifications. • To perform annual vendor assessment in line with Global Vendor Management SOP. • To perform SAP and Track wise audit activities • To perform/ensure risk assessment of vendor/materials in case of critical Quality events or adverse regulatory observations. (WL/Import Alerts/GMP Non-compliance, CEP Suspension) Experience: • 10 to 15 years' experience in pharmaceutical industry Knowledge & Skills: • Well versed with reequipments of ISO 9001:2015, ISO 15378:2017, ISO 13485: 2016 • Experience in Production and Packaging • Computer operating skills and pharmaceutical knowledge • Auditing skills

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