QA Incharge

Roles and responsibilities of QA

• Review standard operating procedure and Providing QMS training to scientists / Analysts.
• Review of vendor documents.
• Handling of change control, Incident & CAPA.
• Data authentication, review, approval, archival and retrieval of Product Development documents (e.g. Protocols, Reports Dossiers etc.)
• R&D Quality Assurance activities to ensure cGLP compliance.
• Review of analytical results and stability protocols of injectables and APIs
• Should have knowledge on data integrity systems of product development
• Evaluate the lab practices regularly as per defined standards, Conduct internal audits & proper documentations
• Assistance in Product Life Cycle Management by updating and tracking activities and documents to support regulatory interface.