Vendor Management - Assocciate Manager /Manager

As a member of the Central Quality department, your role involves: - Conducting Vendor Audit & Compliances - Reviewing Procurement bill of material (PBOM) - Initiating and evaluating change control, Corrective and Preventive Actions (CAPA) through track wise software - Evaluating Certificate of Suitability (CEP) updation, Drug Master File (DMF) notification, and Vendor notification for implementation at formulation sites - Reviewing Quality Management System (QMS) documents of all sites - Auditing formulation sites as per self-inspection plan - Preparing Audit planner for Active Pharmaceuticals Ingredients, Excipients, packing materials, Key Starting Materials (KSM)/Intermediates, Sterile articles, Vaccine Materials, Service provider, Contract laboratories - Assigning source of Active Pharmaceuticals Ingredients, excipients, packing materials in SAP based on availability of documents - Extending retest period of Active Pharmaceuticals Ingredients, excipients, and packing materials in SAP - Updating shelf life, storage conditions, Retest/Expiry flag, and inspection interval data in SAP for Active Pharmaceuticals Ingredients, excipients, and packing materials - Reviewing and approving new and revised specifications and standard test procedures of drug substance, excipients, packaging materials, and drug products - Performing impact assessment of drug products manufactured at formulation site in case of any critical observation/GMP alert received at vendor sites - Preparing and reviewing Nitrosamine and Azide Impurity Assessment reports - Reviewing Technical documents of Active Pharmaceuticals Ingredients, excipients, packing material, KSM/Intermediates, Service provider, sterile articles, vaccine materials, and External Testing laboratory - Providing support to manufacturing sites during regulatory and customer audits - Undertaking any other activity assigned by HOD as and when required Please note that the job involves various responsibilities related to auditing, compliance, documentation review, and support during audits to ensure quality standards are met effectively.,