Nilesh Dhage
Vadodara,GJ
Summary
Experienced QC-AMV Manager with 20 years in the pharmaceutical sector, specializing in HPLC, Ion Chromatography, and Gas Chromatography. Expertise includes leading analytical method development, validation, and transfer activities. Proven track record in ensuring quality standards, navigating regulatory complexities, and driving operational efficiency. Committed to leveraging extensive knowledge to enhance QC processes and contribute to organizational success.
Overview
20
20
years of professional experience
Work History
QC-AMV Manager
Alembic Pharmaceuticals
11.2019 - Current
- Planning, Meeting, event approval, monitoring documentation, execution, communication with other CFT R & D, QA, MS & T and RA
- Meeting with QC/ QC-AMV Head for project status and updating the scenario.
- Filling Document readiness, Consultation queries addressed and implementation of compliance.
- Managed and motivated employees to be productive and engaged in work.
- Accomplished multiple tasks within established timeframes.
- Maintained professional, organized, and safe environment for employees and patrons.
- Maximized performance by monitoring daily activities and mentoring team members.
- Controlled costs to keep business operating within budget and increase profits.
- Established team priorities, maintained schedules and monitored performance.
Assistant Manager
Emcure Pharmaceuticals Ltd
01.2009 - 11.2019
- Supervised day-to-day operations to meet performance, quality and service expectations.
- Monitored cash intake and deposit records, increasing accuracy, and reducing discrepancies.
- Prepared protocols and reports for analytical method validation and transfer, facilitated interdepartmental communication, and coordinated method transfers with Site QC/QA and admixture studies with the formulation department.
- Managed day-to-day laboratory functions, conducted training sessions, and oversaw documentation and archiving of reports and raw data.
- Led audit management, including preparation, conduct, reporting, follow-up, and archiving/destruction of audit documents. Responded to regulatory deficiencies regarding analytical method validation.
Senior Officer
Watson Pharma Private Ltd.
07.2008 - 12.2008
- Analytical method validation and method transfer activity for given projects.
- Involved in first ANDA filling for Watson from India, helping the ANDA Goa team for exhibit batch analysis. Eg. Solid dosage forms.
- Developed and implemented new filing systems to improve organizational efficiency and productivity.
Senior Analyst
Micro Labs Ltd API
04.2006 - 06.2008
- Sr. Analyst for analytical method development, simultaneously the analytical method validation and method transfer activity at other sites (Goa) for given projects.
- Learning experience for handling different instruments and software's, analytical development, analytical validation and their transfer activities. Eg. Solid dosage forms tablets and Capsules…
Pharmacist Intern
Emcure Pharmaceuticals Pvt Ltd.
03.2004 - 04.2006
- Pharmacist for routine analytical activity for all finished as well raw material for given product.
- IPQA rounds within the unit, exposure for the manufacturing process of tables for products of Novartis and GSK at our location.
- Major hands on Serratiopeptidase API and formulation analytical activity.
Education
Master of Science - Biotechnology
YCMO University
Pune, IndiaBachelor's in Pharmacy - Pharmaceutical Sciences
Savitribai Phule Pune University
Pune, India Diploma in Pharmacy -
MSBTE
Mumbai, IndiaSkills
- Operations Management
- Business Administration
- Staff Development
- Performance Management
- Policy Implementation
Accomplishments
- FDA, Pune division approval in Chemical & Instrumentation.
Computer Skills
- Ms- office suite 2021
- Internet
- Powerpoint
- Excel Formulas
- Presentation software
Additional Information
- Passport Details: L7080979
- Marital Status: Married
- Hobbies: Listening Music, Playing Cricket, and reading books.
- LinkedIn: https://in.linkedin.com/in/nilesh-dhage-92520721
Timeline
QC-AMV Manager
Alembic Pharmaceuticals
11.2019 - Current
Assistant Manager
Emcure Pharmaceuticals Ltd
01.2009 - 11.2019
Senior Officer
Watson Pharma Private Ltd.
07.2008 - 12.2008
Senior Analyst
Micro Labs Ltd API
04.2006 - 06.2008
Pharmacist Intern
Emcure Pharmaceuticals Pvt Ltd.
03.2004 - 04.2006
Master of Science - Biotechnology
YCMO University
Bachelor's in Pharmacy - Pharmaceutical Sciences
Savitribai Phule Pune University
Diploma in Pharmacy -
MSBTE
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