KAUSTUBH DEOLE

Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

• HPLC: Waters Arc, Agilent, Thermo-Dionex and Shimadzu
• HPLC Software: Chromeleon, Empower, Chemstation, Lab solution & EZchrome
• FTIR: Shimadzu
• UV: Shimadzu
• Dissolution: Electrolab and Labindia.
• Diffusion: Hanson Diffusion and Electrolab

• Development and Validation of analytical methods for Related Substances, Assay and Content uniformity (CU) of drug products by HPLC and UV.
• To perform method verification of API vendor's method as per DMF.
• To perform and review the compatibility study of API with excipients.
• Carryout extensive forced degradation studies of API and drug product to establish the specificity of the method as a part of pre-method validation programmed.

• To perform and prepare report for the method equivalency between Compendial methods of drug product with that of the in-house methods.
• Arrangement of logistics from different vendors required to perform the verification and validation activities of Drug substance and Drug product.
• Preparation of protocol based studies need to be performed at R&D site.
• Preparation of one time study reports for deficiency response to agency.
• Mails and telecommunication with different cross functional teams for preparation and finalization of Specification, Standard testing procedure for API, Excipients and Drug product.
• Communicate with different outside laboratories and CRO's to perform the verification of different In-house and Compendial methods. To provide the comments to their protocol and report till it gets corrected and signed off.
• Compilation of analytical data to be submitted to the quality assurance department to execute the change control for revision of specification or standard testing procedure.
• Experience of handling FDA deficiencies such as Information request, Discipline response letter and complete response letter related to different semisolid products.
• Review and provide analytical data of different studies such Freeze thaw study, Hold time study, Contact part study, In-use study to formulation department for filling purpose

• Date of Birth: 07/20/1982
• Gender: Male
• Nationality: Indian
• Marital Status: Married

1) Worked on ANDA, ROW projects, Russian market.

2) Experience of handling product queries received from multiple agencies.

3) Support to Regulatory department for product filling and query response.

4) Technical support to manufacturing units related to product or analytical method queries.