Vinayak Daphal
Analytical Scientist | Pharma R&D | Expert in Method Development, Validation & Tech Transfer | ICH & GLP Compliant | Project Management Certified | Driving Quality, Compliance & Innovation
- Role
- Senior Manager - (Analytical Development - Anda) at Medley Pharmaceuticals Ltd
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Vinayak Daphal
As an Analytical Scientist with a strong background in pharmaceutical R&D, I specialize…
Experience
Senior Manager - (Analytical Development - Anda)
Nov 2018 — Present · Mumbai, IN
Overall Key Result Areas:• Efficiently spearheading teams of analytical chemists in the Analytical Research Laboratory/Quality control laboratory for regulatory and non-regulatory projects for analytical method validation activity• Played a vital role in vast gamut of tasks like – providing analytical support for product development process in accordance to ICH guidelines; client interaction; resolving queries and choosing the further strategy for the projects• Instrumental in organising/planning, interfacing with manufacturing units/external companies, third party unit for carrying out error free analysis, method validations as per regulatory requirements within timelines • Significant contribution in wide array of tasks such as – collaborating method development/validation (severe testing of methods to safeguard they are specific/accurate/reproducible/flawless to the product); product development in sync with the set timeframe; formulating/reviewing detailed documents clarifying the work with reference to the product stability and so on• Integral role in supervising stability study by timely keeping, withdrawal of samples, compilation of analysis reports ensuring adherence to drug administration regulatory requirements; managing Annual Maintenance Contracts of all instruments
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