Posted:1 week ago|
Platform:
Work from Office
Full Time
Manager/ Sr. Manager - Quality Control Sterile Injectable & Ophthalmic Formulations Must have prior experience working in USFDA-regulated manufacturing facilities , ensuring adherence to cGMP and regulatory standards. Should possess hands-on exposure to sterile injectable and ophthalmic formulations , including associated analytical requirements. Responsible for planning and executing day-to-day activities related to the analysis of: In-process samples Finished product samples Stability samples Cleaning validation samples Process validation samples Review and approve: Analytical test procedures Product specifications Standard Operating Procedures (SOPs) Stability protocols Summary and analytical reports Ensure timely analysis and release of all sample types in line with the agreed Turn-Around Time (TAT) . Lead investigation, documentation, and timely closure of any OOS (Out of Specification), OOT (Out of Trend), and laboratory incidents within the assigned section. Proficient in the use of laboratory software and systems such as: LIMS (Laboratory Information Management System) TrackWise (for deviation and CAPA management) Documentum (for document control and archiving)
Alembic Pharmaceuticals
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