Experience

Zenovel

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Managing Director & CEO

  • Sep 2020 - Present



Pharmazone

• India
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Director

  • Apr 2010 - Sep 2020

  - Heading all technical operations at Pharmazone.- Involve in Business development of Pharmazone Services- Day to day interaction with Sponsor companies for all the aspects of projects- Recruitment, training of new employees and proper delegation of duties.- Heading Quality Assurance Department as an in-charge Manager-QMS at Pharmazone.- Preparation of working SOPs, manuals, HR & Administrative policies for Pharmazone- Heading Quality Assurance Department at Pharmazone.- Day to day interaction with Sponsor companies for all the aspects of projects- Recruitment, training of new employees and proper delegation of duties.- Preparation of working SOPs, manuals, HR & Administrative policies for Pharmazone- Continuous efforts to make Pharmazone a successful name in the market as a Pharmaceutical Support Service company.Bio Analytical Research monitoring (more than 250) & Clinical Phase monitoring (More than 40) of Bio-Availability/Bio-Equivalence (BA/BE) studies of different clients at different Clinical Research Organisations (CROs)• Experience in conducting Facility & System Audit/Site qualification Audit of BA/BE Labs in Clinical research organisations like Fortis clinical research Pvt. Ltd. (Faridabad-Delhi), Accutest Research Laboratories (Mumbai & Ahmedabad facility), Micro Therapeutic Research Labs Private Limited (MTR) (Chennai), Synapse Labs (Pune), Ecron AcuNova (Manipal), AXIS clinicals LTD.(Hyderabad), Cliantha Research Ltd. (Ahmedabad & Vadodara), Veeda clinical Research Pvt. Ltd. (Ahmedabad), Synchron Research Pvt Ltd. (Ahmedabad), Syngene International (Bangalore) and Lotus Labs (Bangalore) on behalf of various clients. • Have experience in conducting Retro GCP-GLP compliance Audits of already completed studies before their submission to regulatory (like EMEA, TGA & FDA)• Have done, GLP compliance Audit for FDA submissions in CRO called Triumpharma in Amman, Jordan.• Audited top 10 CROs in India.



Alembic Pharmaceuticals Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Scientist

  • Sep 2007 - Apr 2010

  1. Bioanalytical Method development, Method validation and Study sample analysis as per USFDA, EUROPEAN, ANVISA and other regulatory guidelines.2. Actively involved in Bioequivalence study, Method development and Method validation of drugs in biological fluids like blood and plasma using LC-MS/MS and HPLC.3. Data compliance and Bioanalytical report preparation. i.e. Method Validation Report, Bioanalytical study report.4. Ensuring total compliance with Good Laboratory Practices’ norms.5. Preparation method specific as well as operation specific SOPs and their timely updation.6. Having good hands on operating LC-MS/MS(API 4000, API 3000, API 2000) with analyst software versions 1.4.1 & 1.4.27. Online documentation, raw data recording, chromatographic data preparation, log book recording, reconciliation of raw data forms and Method Book Writing.8. Other responsibilities were to keep abreast of the recent trends & methodologies, suggestions to improve the documentation as well as practice during work to train and guide juniors9. Periodic performance verification of and calibration of HPLC systems.10. Calibration and Maintenance of Micro balance and analytical balance.11. Calibration of micro pipettes, multi pipettes and pH meters.12. Maintenance of reference standards.13. Archiving of study data, method validation data, partial & pre method validation data, method development and other Calibration and Maintenance data.14. Actively involved in auditing of CROs when particular studies were to be outsourced. 15. Also handled monitoring responsibilities during and after project sample analysis in case where study sample analysis is outsourced. It was including preparing monitoring agenda, In Process check of all raw data, SOP review, MV report check, Retrospective review of all data and Bioanalytical Report checking. Sending monitoring report to CRO and provide them required follow up for observations was additional responsibility.