6 - 10 years
5 - 10 Lacs
Posted:1 month ago|
Platform:
Work from Office
Full Time
To prepare and review vendor qualification SOP, Contract Service Provider and Contract Manufacturing in line with current regulatory requirements To review and compilation of vendor qualification documents & to carry out Vendor Qualification/ Requalification, Service provider Qualification/ Requalification activity and Contract Manufacturer Qualification/Requalification activity. To perform risk assessment, performance evaluation of vendors, handling of change notifications. Handling of Vendor complaint management system. To maintain QM Info record in SAP & to block the materials in SAP. Updating & maintaining the Vendor list, Technical Agreements for Raw material, Packing material, Service provider and contract manufacturers. Responsible for Vendor Audit and Compliance of Vendors for Key Starting Materials, Advance Intermediates, APIs, Excipients, Primary Packaging Material, Secondary Printed Packaging Material, Contract Service Providers and Third Party Manufacturing Sites To prepare and review system related SOPs and other CQA SOPs/ documents respectively. To handle Customer/ Regulatory Audits relevant to vendor qualification activity. To review, approval of quality management documents i.e. change control. Deviation, Risk Assessment relevant to vendor qualification activity.
Alembic Pharmaceuticals
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