Dharmendra Kanwarjani
Paisley
Summary
Dedicated pharmaceutical professional with a robust background in quality control and compliance role within Pharmaceutical industry. Recently concluded MSc in Pharmaceutical Analysis at the University of Strathclyde, Glasgow, UK. Skilled in product specifications, analytical test methods, regulatory compliance, and effective communication. Eager to leverage expertise in ensuring global product development and quality.
Overview
8
8
years of professional experience
Work History
EXECUTIVE, QUALITY COMPLIANCE & E-LAB
APOTEX RESEARCH PVT. LTD
12.2021 - 08.2023
- Regular tasks such as creation, review and revision of LIMS specifications and Analytical test methods for various formulations, raw materials, API and packaging materials using labware LIMS
- Initiated and evaluated change controls and CAPA for LIMS specifications & Analytical test methods
- Collaborated with regulatory, procurement, QC, R&D and QA teams from time to time for smooth running of CAPA's and change controls for various projects
- Led a successful project for creation of packaging specifications and marketed formulations for product launch and regulatory filing
- Achieved award and appreciation for zero error and timely completion of project for product launch
ASSOCIATE ANALYST, STABILITY OPERATIONS QC
JANSSEN
06.2017 - 12.2021
- Handled analytical instruments while performing various analytical techniques during both product analysis and product review for stability samples (API and formulations)
- Performed investigations and root cause analysis as investigation owner collaborating with QA for OOS, OOT and OOL during analysis of stability samples through track-wise
- Successfully led method transfer project for drug Apalutamide Tablet, which was a part of regulatory filing as well as market product launch
- Collaborated with analytical development team and successfully completed validation project as per ICH guidelines for drug Miconazole nitrate cream (HPLC and Titration)
- Completed train the trainer program and emerged as young trainer in the department
- Appreciation award for meeting the stability time-lines for performing product analysis
QC CHEMIST, QUALITY CONTROL
INGA LABORATORIES PVT. LTD
01.2016 - 05.2017
- Learned and handled analytical instruments to perform various analytical techniques during product analysis and performed product review for stability samples (API and formulations)
- Closely contributed for investigations and root causes related to OOS, OOT and OOL related to stability samples and handled CAPA and corresponding changes through track-wise
Education
Master of Science - Pharmaceutical Analysis
UNIVERSITY OF STRATHCLYDE
08.2024
Bachelor of Science - Pharmacy
PRIN. K.M. KUNDNANI COLLEGE OF PHARMACY
07.2014
Skills
- Non-conformance (OOS, OOT & OOL)
- CAPA's & Change control management
- Validation & Method transfer
- Drafting of technical documents
- Risk Assessments
- Root cause analysis
Hobbies and Interests
Running, Gym, Swimming, Cricket, Travel, Meditation, Yoga, Cooking, Reading, Science fiction, Historical fiction
Disclaimer & Declaration
I will be holding graduate visa from 11/01/24 onwards for 2 years. Thus, no requirement for sponsorship. References will be available upon request. I hereby declare that all the above statements and facts are true, complete and correct to the best of my knowledge and belief.
Timeline
EXECUTIVE, QUALITY COMPLIANCE & E-LAB
APOTEX RESEARCH PVT. LTD
12.2021 - 08.2023
ASSOCIATE ANALYST, STABILITY OPERATIONS QC
JANSSEN
06.2017 - 12.2021
QC CHEMIST, QUALITY CONTROL
INGA LABORATORIES PVT. LTD
01.2016 - 05.2017
Bachelor of Science - Pharmacy
PRIN. K.M. KUNDNANI COLLEGE OF PHARMACY
Master of Science - Pharmaceutical Analysis
UNIVERSITY OF STRATHCLYDE
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