Job DescriptionFunction/Department : QA - In Process (Drug Product Injectables)
NTitle: Manager/Lead
NJob Location: Genome Valley, Shamirpet, Hyderabad
NJob Description:
N
n
Provide line clearance and in-process QA oversight throughout manufacturing and packing operations. N
Ensure compliance with SOPs, BMRs, BPRs, protocols, GMP and GDP requirements. N
Perform and coordinate stage-wise sampling, finished-product, stability, cleaning, and control sample activities, including batch release in SAP. N
Review and approve BMRs, BPRs, protocols, SOPs, reports, logbooks, and manufacturing documents. N
Perform AQL inspections, control sample inspections, and prepare AQL trends. N
Monitor and review media fills, NVPC trends, critical alarms, audit trails, BMS reports, and sterilizer records. N
Manage visual inspection qualification, including defect sets, test sets, and inspector qualification. N




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

📌 Qa In Process Drug Product Injectables Bomraspet
🏢 Biological E
📍 Bomraspet