Operations Oversight: Supervise daily output for solid dosage lines, covering weighing, granulation, blending, compression, and coating.
Compliance & Documentation: Review and verify Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in full adherence to Good Documentation Practices (GDP).
Quality & Safety: Enforce strict adherence to safety protocols, hygiene standards, gowning requirements, and cross-contamination prevention guidelines.
...
Formulation & Process Development: Design, execute, and evaluate laboratory-scale formulation trials to develop stable, robust, and cost-effective generic products.
Pre-formulation & Compatibility Studies: Conduct pre-formulation evaluations, including API characterization, polymorphic studies, and excipient-API compatibility testing.
Quality by Design (QbD): Apply systematic QbD methodologies to establish Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
...