4-5

To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity/Qualification, Scale Up factor calculations & annual requirements.

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.

Performing real-time monitoring of manufacturing and packaging operations to ensure adherence to established processes.

B.Pharm / M.Sc. - Review analytical & electronic QC data with tight QMS grip on incidents, OOS & OOT.

ITI / Diploma for Operators (Sterile USFDA Exp.) B.Pharm / M.Pharm for Officer (Sterile USFDA Exp.)

Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts, Clinical Research Associate at Sun Pharma