- 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.

📌 Quality Assurance - IPQA Lead (Hyderabad)
🏢 Biological E
📍 Hyderabad