QA - In Process; Drug Product Injectables

Position: QA - In Process (Drug Product Injectables)
Function/Department : QA - In Process (Drug Product Injectables)
Title :
Manager/Lead

Job Location:

Genome Valley, Shamirpet, Hyderabad

Job 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.