Hyderabad

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Key Responsibilities

Lead and manage the Quality Control function for Sterile Injectables and Vaccine manufacturing.

Oversee Chemical, Microbiology, Environmental Monitoring, Sterility Testing, Stability, and Biological Testing laboratories.

Ensure compliance with cGMP, GLP, WHO-GMP, US FDA, EU GMP, MHRA, PIC/S, ICH, and Schedule M requirements.

Review and approve analytical reports, Certificates of Analysis (COA), specifications, protocols, SOPs, and laboratory documentation.

Ensure timely testing and release of raw materials, packaging materials, in-process samples, finished products, and stability samples.

Supervise sterility testing, endotoxin (BET), particulate matter testing, microbial limit testing, bioburden testing, media fill support, and environmental monitoring programs.

Manage analytical method validation, method transfer, method verification, and stability studies in accordance with ICH guidelines.

Review and investigate OOS, OOT, laboratory deviations, CAPA,



change controls, and laboratory incidents.

Ensure qualification, calibration, maintenance, and lifecycle management of laboratory equipment.

Ensure compliance with Data Integrity (ALCOA+) principles and laboratory documentation practices.

Support internal audits, customer audits, and global regulatory inspections, ensuring timely closure of observations.

Collaborate with QA, Manufacturing, Engineering, Validation, Regulatory Affairs, R&D;, and Supply Chain teams to ensure product quality and regulatory compliance.

Drive continuous improvement initiatives to enhance laboratory efficiency, compliance, and operational excellence.

Lead, mentor, and develop QC teams through training, coaching, and performance management.

Location Hyderabad
Website [email protected]
Salary Best in Industry
EXPERIENCE NEED Minimum 15 Years

📌 Quality Control (Hyderabad)
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📍 Hyderabad