QA Officer

Role Overview

To ensure effective control, preparation, review, issuance, archival, and retrieval of GMP documentation for Buffer manufacturing in compliance with regulatory requirements and company quality systems.

Responsibilities

• Document Lifecycle Management: Handle control, issuance, reconciliation, revision, archival, and retrieval of master GMP documents (SOPs, BMR/BPR, STPs, specifications, protocols, and logbooks).
• Shop-Floor QA & Line Clearance: Perform routine GMP surveillance and line clearances across buffer operations, including raw material dispensing, compounding/manufacturing, filtration, filling, sterilization, visual inspection, and packaging.
• Batch Record Review & Quality Systems: Review executed batch records and support quality systems documentation, including Change Controls, Deviations, CAPAs, and Risk Assessments.
• Process Verification & Release Support: Verify inline parameters and critical process steps to support batch release recommendations and ensure continuous regulatory compliance.