Executive - Quality Assurance

Job description

Job Description • Visiting to DS manufacturing and warehouse facility to ensure that activities are being carried out by following GMP requirements, Regulatory requirement and as per approved procedures. • To participate in the manufacturing investigation and CAPA finalization activity. • Preparation and review the Risk Assessment and Mitigation Plan. • Ensure that process and cleaning validation activities are being carried out by following approved protocols. • Review of master document like study protocol, BPR, MFR etc. • Review of executed Batch Processing Records for Batch Release. • Review of Batch Dispatch Record and verification of dispatch activities in warehouse. • Overall coordination for the APQR data compilation and APQR preparation activity. • Preparation and review of Quality System SOPs & documents. • Review of SOPs as per GMP requirements for all departments. Work Experience 3 to 5 Years Education Masters in Biotechnology