AM/DM-Development Quality Assurance

About Client:

It Is specializing in manufacturing Active Pharmaceutical Ingredients (APIs), custom synthesis, and peptide services.



Job Role: - AM/DM - Development Quality Asurance 



 

•  Handling and evaluation of QMS activities (incidents, change controls, deviations, Internal


• audits, etc.).


• Ensure documentation complies with data integrity and compliance with ALCOA+ principles.


•  Review of Process development (Development report, risk assessment, Spec. justification


• etc..) and analytical documents (development reports, spec and MOA and method validation


• documents).


•  Review of Vendor qualification documents


•  Ensure effective root cause analysis (RCA) and CAPA for investigations


• (OOS/OOT/Incidents/deviations).


•  Handling of phase gate and...