Function/Department : QA - In Process (Drug Product Injectables)Title : Manager/LeadJob Location: Genome Valley, Shamirpet, HyderabadJob Description:- 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) (Khammam)
🏢 Biological E
📍 Khammam