Shreeyash R. Tapale

Perform Method development and Validation of solid orals and APIs for human and veterinary use for US and European markets.

Review of analytical data and interpret results.

Method transfer and troubleshooting at Plant (QC)site.

Conduct literature search.

Regulatory Query Response and Preparation of STPs, MDR, MVR, DDR and Protocols

Perform Routine and Stability analysis for test like Assay, Related substances, Water by KF, Dissolution and UOD.

Cross functional team support and compliance wrt cGMP.

Additional Responsibility: Stability data management and lab audit compliance

• Perform Method development and Validation for solid orals and APIs for India Market.
• Pilot Bio related activities (Method readyness and Method Transfer) and BE NOC document preparation.
• Calibration of analytical instrument as per yearly schedule of HPLC, UPLC, Dissolution apparatus, Karl fisher apparatus and Balances.
• Pharmacopial method equivalency reports and testing.
• Excipient testing and release as per specification
• Maintained clean, safe working environments to eliminate accident risks.
• Additional Responsibility: Engaged with department heads to identify and address safety practices in lab and training colleagues over same .

• Perform Analytical Method Developmet and Validation for solid orals and APIs (Oncology) for US, Europe and ROW market.
• Forced degradation study.
• Knowledge on product end to end requirement for submission and filing.
• Knowledge of GLP, GDP, GMP, and Regulatory Requirements for testing and validation procedures.(ICH guidelines)
• Performed lab activities with ALCOA++ measures.
• Performed Routine analysis using instrument like HPLC, GC, KF, UPLC, Dissolution apparatus (Type 1-7)
• Additional Responsibility: Lab setup with and SOP preparation

• Method validation and Revalidation as per regulatory requirement.
• Standard Preparation and Impurity profiling
• Protocol/Report preparation, execution and review.
• Additional Responsibility: Laboratory glassware managemet and procurement.

• Assisted in routine/stability analysis and check for trend data.
• Report OOC/ OOT results
• Collaborated with team members to achieve project target.
• Learning good lab practices.