Job DescriptionFunction/Department : QA - In Process (Drug Product Injectables)
NTitle: Manager/Lead
NJob Location: Genome Valley, Shamirpet, Hyderabad
NJob Description:
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- 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