01Overview
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 endTo 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 activitiesTo 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: 2016Experience in Production and PackagingComputer operating skills and pharmaceutical knowledgeAuditing skills .