AMDM-Development Quality Assurance

Hyderabad - India

Monthly Salary: Not Disclosed

Posted on: 4 days ago

Vacancies: 1 Vacancy

Job Summary

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.

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 Internalaudits etc.).Ensure documentation...