Perform testing of incoming raw material samples (e.g., FTIR, identity by wet chemistry, reagent preparation, sample receiving).
Manage and store raw material samples in compliance with cGMP.
Perform analytical testing and documentation for raw materials, API, drug substances/products, packaging materials, complaints, and stability samples.
Conduct stability testing, sample storage, and documentation (if not centralized).
Maintain QC Raw Materials laboratory in full cGMP compliance.
Execute method validation/verification and routine release testing for raw materials.
Perform data entry and review of RM packages for batch release.
Support laboratory improvement projects, investigations (OOS, deviations), and change controls.
Prepare for and participate in internal audits and health authority inspections.
Undertake other duties or projects as assigned by the Section Manager.
HSE
Comply with all HSE policies and guidelines.
Identify, report, and propose solutions for potential hazards and risks.
* Actively participate in initial and ongoing safety training.
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