Analytical Quality Assurance Associate - Biosimilars

full-time Business Operations Specialists

Job Description

Job summary

We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards.



Roles & Responsibilities

• Involve in Analytical data review and Approval.
• Review of batch analytical record for batches manufactured at CMO.
• Review and Approvals of analytical Method Transfer, Validation Protocol and Reports.
• Preparation, Review and Approvals of Study protocols and Reports.
• Review and Approvals of stability Protocols, Reports and related documentation generated from the stability studies of the products.
• Preparation, Review and Appro...