Job Description

Function/Department : QA - In Process (Drug Product Injectables)

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Title : Manager/Lead

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Job Location: Genome Valley, Shamirpet, Hyderabad

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Job Description:

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- Provide line clearance and in-process QA oversight throughout manufacturing and packing operations.
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- Ensure compliance with SOPs, BMRs, BPRs, protocols, GMP and GDP requirements.
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- Perform and coordinate stage-wise sampling, finished-product, stability, cleaning, and control sample activities, including batch release in SAP.
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- Review and approve BMRs, BPRs, protocols, SOPs, reports, logbooks, and manufacturing documents.
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- Perform AQL inspections, control sample inspections, and prepare AQL trends.
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- Monitor and review media fills, NVPC trends, critical alarms, audit trails, BMS reports, and sterilizer records.
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- Manage visual inspection qualification, including defect sets, test sets, and inspector qualification.
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- Assess manufacturing breakdowns, deviations, investigations, CAPAs, change controls, and market complaints for timely closure.
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- Support gowning qualification, personnel training, and competency/qualification of manufacturing staff.
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- Ensure timely identification and escalation of significant quality issues to senior management.
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- Participate in regulatory and customer audits and implement audit remediation actions.
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- Prepare and review CPV, APQR, AQL, and other quality-related reports and trends.
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- Coordinate with cross-functional teams including RA to maintain compliant operations.
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- Review and approve manufacturing staff job descriptions and related quality documentation.
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- Act as Designee to the IPQA Lead when required.
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📌 QA - In Process (Drug Product Injectables) (Bomraspet)
🏢 Biological E
📍 Bomraspet