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 Tech. transfer activities.
•  Collaborate on resolving any g...