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 gaps or issues identified during the technology transfer process.
•  Oversee DQA requirements during scale-up and technology transfer to manufacturing.
•  Foster a culture of compliance, ownership, and continuous improvement.
•  Handling of customer calls related to CMS projects and ensuring address of all customers
• related queries within the timeline.
•  Participating in the teleconferences to clarify the customer queries.
•  Coordination with Cross-functional teams to meet the project timelines.