Prepare, Review and Approval of COA.
Review and Approval of stability protocols, reports, and summary reports.
Prepare justification for reduction of tests for Input material testing such as raw and packaging material; In-process testing; Finished product testing; Stability testing; Microbial testing.
Prepare and review of specification/Method of analysis.
Initiation, evaluation of Change control.
Review of vendor qualification documents.
Handling of item codification.
Technical Skill Required
Analytical documentation : Advanced
ICH Guidelines : Advanced
Stability Management : Advanced
QMS Automation System : Intermediate
US Guidelines : Advanced
B- Pharmacy
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