Commercial product/ stability batches / exhibit batches / characterization Batches – Master Batch Manufacturing Record and Master Batch Packaging Record.
Risk Assessment, Process Validation protocol, Incident and Investigation report, action, compliance, and closure.
CAPA plan and closure.
Protocols and reports.
Internal Quality Audit/ Regulatory Quality Audit Compliance and closure.
Change, control, Standard Operating Procedure, Planned Modification.
Other quality documents including amendments.
To assist the Plant head in Batch Manufacturing, Warehouse and controlling the functions related to General oral solid dosage department. To plan and execute the schedule as per work plan.
To ensure the achievement of Production and Warehouse output with respect to Quality and commercial demands.
Qualification & Experience
B.Pharm / M.Pharm
Experience
Tenure : 19+ Years (with recent USFDA experience & Wrap matrix molecules with Oros technology and Potent Molecules handling)