AGM - IPQA - Injectable

Hetero

16 - 20 years

19 - 22 Lacs

jadcherla

Posted:2 hours ago| Platform:

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Skills Required

usfda ipqa injectables sterile oncology

Work Mode

Work from Office

Job Type

Full Time

Job Description

Overall responsibility for
In-Process Quality Assurance (IPQA)
activities for
Injectable manufacturing
(SVP/LVP/Oncology).
Ensure compliance with
cGMP, GLP, GDP
, and data integrity requirements.
Review and approval of
Batch Manufacturing Records (BMR/BPR)
, in-process controls, and line clearance.
Handling and closure of
Deviations, OOS, OOT, Change Controls, CAPA
, and Risk Assessments.
Review and approval of
SOPs, protocols, validation documents
, and technical reports.
Ensure compliance during
Regulatory Audits
(USFDA, EU-GMP, WHO, ANVISA, TGA, MHRA, etc.).
Lead and mentor IPQA teams across
Compounding, Filling, Visual Inspection, Lyophilization, Autoclaves
.
Monitoring of
aseptic practices
, gowning qualification, media fills, and environmental monitoring.
Coordination with Production, QC, Engineering, Validation, and Regulatory Affairs.
Ensure adherence to
ALCOA+ and Data Integrity
principles.
Drive continuous improvement and quality culture initiatives.

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