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Theon Pharmaceuticals
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Senior Manager Quality Control, Sterile Plant

Senior Manager Quality Control, Sterile Plant

Theon Pharmaceuticals

10 - 15 years

|

10 - 18 Lacs

Posted:1 hour ago| Platform:

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Skills Required

injectables usfda formulation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Senior Manager Quality Control

Role & responsibilities

ead the Quality Control Department for sterile manufacturing operations
Ensure compliance with
cGMP, GLP, USFDA, EU GMP, WHO, and other regulatory guidelines
Oversee chemical, instrumental, and microbiological QC activities for sterile products
Review and approve analytical data, OOS/OOT investigations, SOPs, protocols, and reports
Ensure timely testing and release of raw materials, packaging materials, in-process, and finished products
Manage QC laboratories including
HPLC, GC, UV, Dissolution, TOC, and other analytical instruments
Support and face regulatory audits and inspections; prepare responses and implement CAPAs
Ensure data integrity, ALCOA+ compliance, and laboratory safety standards
Lead method validation, method transfer, stability studies, and AMV activities
Develop, train, and mentor QC team members
Collaborate with QA, Production, Microbiology, and Engineering teams

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Theon Pharmaceuticals

Biopharmaceuticals

New York

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