Function/Department : QA - In Process (Drug Product Injectables)

Title : Manager/Lead

Job Location: Genome Valley, Shamirpet, Hyderabad

- Provide line clearance and in-process QA oversight throughout manufacturing and packing operations. - Ensure compliance with SOPs, BMRs, BPRs, protocols, GMP and GDP requirements. - Perform and coordinate stage-wise sampling, finished-product, stability, cleaning, and control sample activities, including batch release in SAP. - Review and approve BMRs, BPRs, protocols, SOPs, reports, logbooks, and manufacturing documents. - Perform AQL inspections, control sample inspections, and prepare AQL trends. - Monitor and review media fills, NVPC trends, critical alarms, audit trails, BMS reports, and sterilizer records. - Manage visual inspection qualification, including defect sets, test sets, and inspector qualification. - Assess manufacturing breakdowns, deviations,



investigations, CAPAs, change controls, and market complaints for timely closure. - Support gowning qualification, personnel training, and competency/qualification of manufacturing staff. - Ensure timely identification and escalation of significant quality issues to senior management. - Participate in regulatory and customer audits and implement audit remediation actions. - Prepare and review CPV, APQR, AQL, and other quality-related reports and trends. - Coordinate with cross-functional teams including RA to maintain compliant operations. - Review and approve manufacturing staff job descriptions and related quality documentation. - Act as Designee to the IPQA Lead when required.

📌 QA - In Process (Drug Product Injectables) (Malkaram)
🏢 Biological E
📍 Malkaram