Mahesh Deshmukh
Wakad, Pune
Summary
13 years work experience in quality control and analytical development laboratory for Pharma and Biopharmaceutical sector having sound knowledge of different analytical techniques under compliance,Data Integrity,ALCOA,21 CFR, GLP,GDP.
Overview
15
15
years of professional experience
Work History
Research Executive -ADL
IPCA LTD
Mumbai
06.2024 - Current
- Analysis of in-process samples, Stability samples, Final Drug substance, Final Drug products of Biosimilar's in ADL lab by following SOP and MOA.
- Hands on different analytical instrument like HPLC, UPLC, UV Spectrophotometer, Solo VpE.
- Review of sequences and logbooks as a secondary analyst.
- Periodic review of SOP, updating of MOA as per change control.
- Involving in investigation analysis as per customer requirement.
- Involving in method qualification activities, tech transfer activities as per requirement.
- Calibration of pH meter and Analytical balance.
- Online documentation and data entry in day to day working.
- Maintain Lab in day to day working.
- Having Knowledge of compliance, ICH, pharmacopoeia. Data integrity, ALCOA.
- Involved in analyst qualification activities of colleagues and junior analyst.
- Work Environment and Tools: Waters and Shimadzu HPLC with empower software and Waters UPLC with empower software.
Executive-QC
Lupin Biotech
Pune
11.2021 - 07.2023
- Hands on experience of handling Biotech in-process, DS and DP products.
- Analysis of in-process samples, Stability samples, Final Drug substance, Final Drug products in Biotech mammalian quality control laboratory by following SOP and STP.
- Hands on different analytical instrument like HPLC, pH meter, Capillary electrophoresis under GLP environment.
- Online data reporting, preparation of report and relies of batches.
- Using EDMS for online instrument entries, QAMS for LIR reports, LIMS,SAP for analysis in QC lab.
- Performing analysis as per different markets like US, Europe, Canada, Japan, ROW, Local Indian etc.
- Review of sequences and logbooks as a secondary analyst.
- Compliance to various cGMP practices and internal SOPs.
- Reporting incidents that happened during day-to-day QC activities.
- Calibration of pH meter and Analytical balance.
- Online documentation and data entry in day to day working.
- Maintain Lab as per cGLP in day to day working.
- Having Knowledge of compliance, ICH, pharmacopoeia. Data integrity, ALCOA.
- Involved in QAMS activity such as preparing laboratory investigation reports related to analysis performed.
- Involved in analyst qualification activities of colleagues and junior analyst.
- Work Environment and Tools: Chromeleon 6.8 software, 24 karat software, SAP, EDMS, QAMS, LIMS, MS Office and validated excel sheets.
- Analyzed laboratory results to identify trends and deviations in product quality.
Senior Research Executive-ADL
Sava Healthcare
Pune
10.2020 - 11.2021
- Hands on experience of handling Respiratory products such as DPI, MDI, Nasal Spray.
- Analysis of in-process samples, intermediate samples, finished products of respiratory products in AR&D laboratory.
- Analysis of development sample batches, stability samples, market samples for comparison in DPI, MDI and Nasal spray dosage by using different techniques such as spray tech, spray-view, NGI, UDD etc.
- Analysis of Nasal Spray test like spray pattern, Plume geometry and DSD on Spray tech and Spray view instruments.
- Analysis, Method development, method validation of In house Nasal spray products as well as contract products as per requirement.
- Online data reporting, preparation of reports and review of results.
- Performing analysis as per different markets like US, Europe, Canada, Japan, ROW, Local Indian etc.
- Review of sequences and logbooks as a secondary analyst.
- Compliance to various cGMP practices and internal SOPs.
- Calibration of pH meter, Analytical balance, Spray tech and Spray view.
- Online documentation and data entry in day to day working.
- Maintain Lab as per cGLP in day to day working.
- Preparing documents as per regulatory guidelines.
- Having Knowledge of compliance, ICH, pharmacopoeia.
- Work Environment and Tools: Chromeleon 6.8 software, Tiamo software, Viota software, MS Office and validated excel sheets.
Research Executive-ADL
Sai life Sciences Limited
Pune
03.2014 - 01.2020
- Hands on experience of handling different dosage forms such as Tablets, Injectable, lyophilized oncology products.
- Analysis of injectables and lyophilized hold time and compatibility study samples, in-process samples, lab validation batches, deactivation studies, finished products in ADL.
- Analysis of in-process samples, stability batches, hold time samples, Compatibility study by using HPLC, GC, KF, Osmometer, pH in Analytical development laboratory.
- Perform different test like RS, Assay, Water content, Reconstitution time, Osmolarity, Solvent content etc.
- Method development, method validation analysis as per requirement.
- Method transfer to QC lab.
- Online data reporting, preparation of reports and review of results.
- Performing analysis as per different markets like US, Europe, ROW etc.
- Review of sequences and logbooks as a secondary analyst.
- Compliance to various cGMP practices and internal SOP's.
- Reporting incidents that happened during day-to-day ADL and QC activities.
- Calibration of pH meter and Analytical balance.
- Online documentation and data entry in day to day working.
- Maintain Lab as per cGLP in day to day working.
- Preparing documents as per regulatory guidelines.
- Having Knowledge of compliance, ICH, pharmacopoeia.
- Intended chemicals and glassware's as per requirement.
- Work Environment and Tools: Empower 2, Empower 3, Tiamo, Chromeleon, MS Office and validated excel sheets.
Management Staff-QC
Cipla Limited
Goa
02.2013 - 11.2013
- Hands on experience of handling different dosage forms such as Tablets, Capsules.
- Analysis of finished products in formulation quality control lab as per SOP and STP.
- Analysis of finished samples by using KF and Coulometer.
- Online data reporting, preparation of reports.
- Performing analysis as per different markets.
- Compliance to various cGMP practices and internal SOP's.
- Reporting incidents that happened during day-to-day QC activities.
- Online documentation and data entry in day to day working.
- Maintain Lab as per cGLP in day to day working.
- Work Environment and Tools: Tiamo, MS Office and validated excel sheets.
- Completed day-to-day duties accurately and efficiently.
- Contributed innovative ideas and solutions to enhance team performance and outcomes.
Senior Officer- QC
Lupin Limited
Tarapur
11.2010 - 01.2013
- Hands on experience of handling API products.
- Analysis of in-process samples, intermediate samples, recovered solvents, finished products in API quality control laboratory by using HPLC, GC, KF as per SOP and STP.
- Online data reporting, preparation of reports and relies on the reports.
- Performing analysis as per different markets like US, Europe.
- Compliance to various cGMP practices and internal SOPs.
- Reporting incidents that happened during day-to-day QC activities.
- Online documentation and data entry in day to day working.
- Maintain Lab as per cGLP in day to day working.
- Work Environment and Tools: Chromeleon software, Total chrome navigator software, Tiamo software, Validated excel sheets.
Education
Master of Science - Analytical Chemistry
Bharati Vidhyapeeth
Pune01.2010
Bachelor of Science - Chemistry
Shivaji University
01.2008
Skills
- Chromatographic Techniques
- Spectroscopy techniques
- Problem solving
- Regulatory compliance
- Data integrity
- Online documentation
- Teamwork
- Analytical thinking
Instruments Used
- High Performance Liquid Chromatography (Shimadzu, Waters, Agilent, Dionex)
- UPLC (Waters)
- Gas Chromatography (Perkinelmer, Shimadzu)
- U.V. Spectrophotometer
- Spray view by Proveris
- Spraytech
- KF and Coulometer
- PH Meter
- Osmometer
Timeline
Research Executive -ADL
IPCA LTD
06.2024 - Current
Executive-QC
Lupin Biotech
11.2021 - 07.2023
Senior Research Executive-ADL
Sava Healthcare
10.2020 - 11.2021
Research Executive-ADL
Sai life Sciences Limited
03.2014 - 01.2020
Management Staff-QC
Cipla Limited
02.2013 - 11.2013
Senior Officer- QC
Lupin Limited
11.2010 - 01.2013
Master of Science - Analytical Chemistry
Bharati Vidhyapeeth
Bachelor of Science - Chemistry
Shivaji University