VINAYAK. N. DAPHAL
Summary
- Seeking assignments in Analytical method development and validation section with an organization of repute. Professional Summary
- A competent professional with more than 17 years of experience in the areas of analytical method development and validation in the pharmaceutical industry.
- Presently working with Medley Pharmaceuticals Limited, Andheri (East) as Sr. Manager - (Analytical Development-Laboratory).
- Keen administrator with recognized proficiency in managing Quality Assurance Operations entailing Quality, Product Development, Project Management, etc.
- Ensured compliance of various quality measures by maintenance of appropriate Quality Management and Documentation System.
- Gained significant experience in performing method development and method validation for Regulatory Markets like US Market (ANDA), UK Market (MHRA) and domestic markets.
- Possesses a clear understanding to technology trends with distinction of instituting quality control techniques
- Fully conversant with latest GLP and GMP requirements
- Excellent inter-personal, communication and organizational skills with proven abilities in team management, strategic alliances, analysis and planning.
Overview
17
17
years of professional experience
Work History
Sr. Manager
Medley Pharmaceuticals Limited
Andheri, East
11.2018 - Current
- Analytical Development-ANDA)
- Significant Highlights:
- Leading a team of 10 analytical chemists in Analytical Research Laboratory for regulatory and non-regulatory projects
- Also heading a team of 12 analytical chemists in quality control laboratory for regulatory and non-regulatory projects for analytical method validation activity
- Responsible for complete Analytical support for Product development Process as per ICH guidelines
- Interacting with prestigious clients to for their queries and deciding the further strategy for the projects
- Planning, coordinating with manufacturing units and external companies, third party unit for carrying out error free analysis, method validations as per regulatory requirements within stipulated time period
- Coordinating method development & validation i.e
- Rigorous testing of methods to ensure they are precise, accurate, reproducible, "fool-proof" & specific to the product
- Preparation / reviewing detailed documents explaining the work & its results, in terms of product stability
- Ensured product development as per the timelines
- Monitoring stability study by timely keeping, withdrawal of samples & compilation of analysis reports ensuring compliance to drug administration regulatory requirements
- Handling Annual Maintenance Contracts of all instruments.
Assistant Manager
Ajanta Pharma Limited
08.2013 - 10.2018
- Analytical Development-ANDA)
- Significant Highlights:
- Leading a team of 8 analytical chemists in Analytical Research Laboratory for regulatory and non-regulatory projects
- Responsible for complete Analytical support for Product development Process as per ICH guidelines
- Interacting with prestigious clients to for their queries and deciding the further strategy for the projects
- Planning, coordinating with manufacturing units and external companies, third party unit for carrying out error free analysis, method validations as per regulatory requirements within stipulated time period
- Coordinating method development & validation i.e
- Rigorous testing of methods to ensure they are precise, accurate, reproducible, "fool-proof" & specific to the product
- Preparation / reviewing detailed documents explaining the work & its results, in terms of product stability
- Ensured product development as per the timelines
- Monitoring stability study by timely keeping, withdrawal of samples & compilation of analysis reports ensuring compliance to drug administration regulatory requirements
- Handling Annual Maintenance Contracts of all instruments.
Management staff (Group Leader)
Sitec Labs Pvt. Ltd
10.2010 - 07.2013
- Ensured preparation of method development, method validation, technology transfer protocols and reports
- Key role in coordinating with RA, FC, QA, packaging development
- Responsible for performing the Stability study as per ICH guidelines
- Instrumental role in handling more than 8 projects efficiently
- Ensured project development as per the timelines
- Performed ANDA project work whereby prepared Timelines for the project
- Fully conversant with latest GLP and GMP requirements
- Ensured correspondence with formulation development and regulatory affairs department
- Developed Analytical Method for new formulations
- Performed the Analytical Method Validation as per ICH guidelines
- SOP preparation and training
- Performed the Cleaning Validation
- Key Projects Handled:
- Handled various formulations such as Tablet dosage forms, capsules, ophthalmic, ointments, syrups, etc.
Management Staff Member
PHARMASOLVE SPECIALITIES (I) Pvt. Limited
Vikhroli, West
10.2005 - 09.2010
- Staff
- Significant Highlights:
- Instrumental in analytical method validation, calibration, servicing and maintenance of instruments & ensuring SOP preparation
- Co-ordination with loan license party and handling market complaints
- Steered the instruments calibration & instrumental and chemical analysis
- Significant role in driving the Technology Transfer
- Responsible for instrumental and chemical analysis.
- Streamlined and monitored quality programs to alleviate overdue compliance activities.
- Communicated best practices among on-site and external personnel to align efforts and goals.
Education
Ph.D - Chemistry
JJTU University
M.Sc. - Chemistry
Kuvempu University
Advanced Diploma - Analytical and Technical Chemistry
MET"s Institute of Medical Science
B.Sc. - Chemistry
Mumbai University
Diploma - Computer Software
Accomplishments
- Participated in sports held by Ajanta Pharma's Annual Sports Day & dance at Ajanta Pharma's foundation day
- Participated and Secured First prize in Poster presentation at the two day National Seminar on Recent Advances In Analytical Techniques(RAAT's-2012) Organized by Birla College (Mumbai University)
- IT Purview
- Proficient at Ms-Office Microsoft Project 2007 & Internet Applications.
Affiliations
Attended seminar on:
Seminar by Mr. Sunil Dhuri (Agilent Technology Ltd) on Chromatography.
Seminar by Mr. Kailash Gawde (Waters Alliance) on Method Development.
Workshop for Waters UPLC Method Development.
Timeline
Sr. Manager
Medley Pharmaceuticals Limited
11.2018 - Current
Assistant Manager
Ajanta Pharma Limited
08.2013 - 10.2018
Management staff (Group Leader)
Sitec Labs Pvt. Ltd
10.2010 - 07.2013
Management Staff Member
PHARMASOLVE SPECIALITIES (I) Pvt. Limited
10.2005 - 09.2010
Ph.D - Chemistry
JJTU University
M.Sc. - Chemistry
Kuvempu University
Advanced Diploma - Analytical and Technical Chemistry
MET"s Institute of Medical Science
B.Sc. - Chemistry
Mumbai University
Diploma - Computer Software
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