05 Oct
|
Bu0026S Group
|
India
05 Oct
Bu0026S Group
India
Job Responsibilities
To co-ordinate with different departments like Analytical, Production, QA, QC, Regulatory for smooth technology transfer of recent products and troubleshooting in existing formulations.
To review documents (Laboratory notebooks, SOPs, Protocols, Reports and Specification). Scale-up/Optimization/Validation batches execution and monitoring of solid and liquid dosage forms.
To review literature and patent searches and identify appropriate transfer approach and strategy design to transfer the product.
Review of documents like Master formula card (MFC), BMR, BPR, Product Detail, Scale up protocol and reports, Raw materials and Product Specifications as per Positive Documentation Practice for current products.
Troubleshooting and reformulate Solid oral (Immediate release and Modified release) and liquid oral (Solution & Suspension) dosage forms which are commercialized or manufactured at other hand.
Review of batch size formula (Scale Up / Scale Down), GAP analysis with Process Improvement to improve the productivity and Equipment Equivalency Evaluation across all locations.
Execute and monitor Optimization Batch / Exhibit Batch / Validation Batches at parent and site shift location. Review of trial batch protocol, Process Validation protocol and report, Hold time study protocol and report.
📌 F&d Team Lead Vadodara (India)
🏢 Bu0026S Group
📍 India