04 Oct
|
Bu0026S Group
|
Vadodara
04 Oct
Bu0026S Group
Vadodara
Job Responsibilities
- To co-ordinate with different departments like Analytical, Production, QA, QC, Regulatory for smooth technology transfer of new 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 Good 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)
🏢 Bu0026S Group
📍 Vadodara