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Responsible for review of User Requirement Specification, Design Qualification, FAT Protocols. SAT Protocols, Installation Qualification, Operational Qualification, Performance Qualification Protocols and reports

Looking for suitable candidates for our US FDA approved OSD formulation facility at Paithan, Dist. Chhatrapati Sambhajinagar (Maharashtra)

Must have PhD, Medical degree or Master’s degree (MSc, M Pharm, Pharm D or equivalent) combined with relevant experience.

Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches.

Handling of HPLC, GC, UV and Dissolution & other sophisticated instruments 

Knowledge of Dispensing in warehouse of Raw Material & Packing Material. Manage daily production QMS activities (deviations, OOS/OOT investigations, CAPA, change control) with proficiency in PowerPoint, Excel, Al tools & knowledge of manufacturing process

Opportunity to work with a specialty pharmaceutical CDMO where quality, compliance and execution drive success for our partners’ healthcare programs worldwide.

Manage product registrations, renewals, variations and lifecycle activities. Review SmPC, PIL, artworks, labels and other regulatory documents.

APDM Pharmaceuticals Private Limited has its office in Ahmedabad with all QA and regulatory support staffs for managing CDO and CDMO projects,vendor Audits, BA BA monitoring, project and Engg team.