F&D - Team Lead

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 new 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.