Devangi Amin

Experience

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  Baroque Pharmaceutical Pvt Ltd

  Jul 2015 - Sept 2016

  Formulation & Development Officer

  -Working as a team member to achieve the target without compromising any qualityparameter.-To prepare and maintain documentation of Formulation & Development Department.-Formulation development ( by QBD) for global markets.-Handling of new projects for developments of solid dosage forms like Tablet, capsule,Dry syrup and Liquid dosage forms like Syrup.- Preparation & Review of Qualitative & Quantitative Formula of F&D product.- Participate in scale up exposure for regulated markets and appropriate knowledge aboutregulated market requirement. Exposure in preparing and reviewing documents like PDR,MFR, BMR, etc.- Handling of registration sample for regulatory market (Tablet, Capsule, Dry syrup,Syrup, Packing of formulation) as per party requirement/ Country specific.- To handle stability batches and its documentation of new developed Products. Show less

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  Baroque Pharmaceutics Pvt Ltd

  Oct 2016 - Nov 2017

  Formulation & Development Executive

  -Planning and executing of trials as per QBD and guidelines of ICH as well as respective country in which product to be marketed. Knowledge of cGMP and GLP Guidelines.-Actively participate in Lab scale batches, pilot scale batches in Oral Solid, Liquid formulation like Tablet, Capsule, Oral Suspension and Syrup. Active calculation and batch reconciliation on various stages.-Handling of Troubleshot from production of newly developed formulation and ongoing Production batches at different stage.- To conduct Process Development, Optimization, Scale-up, Pilot-Bio and Exhibit batches.- Coordinate with related departments for execution of projects.- Compilation and writing of Formulation Development Reports and Question Based Review documentation to support regulatory submission.- Review Master Formula Record, Batch manufacturing Process of trial of pilot & commercial Batches- To execute the R&D trials for trouble shooting/ remediation/ tweaking of commercial products. Show less

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  Baroque Therapeutics Pvt Ltd (Research Scientist )

  Nov 2017 - Jan 2018

  Research Associate FDL (Formulation Development Laboratory)

  -Literature survey, pre-formulation studies and formulation trials leading to identifying asuitable composition for the product.- Review patents and literature to identify the best formulation strategies with the head of the department.- Handling of new projects for developments of solid dosage forms like Tablet, capsule,Pelletization process (Fluidization & Wuster Process), Dry syrup and Liquid dosage formslike Syrup and suspension.- Experience in Formulation Development / Validation trials & product optimizationGeneric products development.-Preparation and review of Qualification protocol report of equipment and instrument.(Compression machine, Granulation Area Equipment, Coating, IPQC instrument).-Preparation /review/ Approve of all SOPs , Guideline, Report, PDRs.- Maintained accurate and complete experimental records, providing timely electroniclaboratory notebook, research reports and presentations.- Knowledge of all the equipment's of granulation, compression, coating, wurster process (Glatt)and encapsulation.- Preparation & Review of documents, pre scale-up & tech transfer of various products.- --- -Actively involved in scaling up the process from R&D to Pilot Plant to commercial level.-Anticipate the problem during development of formulation with respect to process andproduct attributes.-Work in coordination with development scientist in R&D and ADL scientists at Plant.- Participate in Regulatory Requirements with respect to documentation, process andproduct attributes.- Supporting post approval activities as necessary.- Training/guiding R&D Technicians for execution of the batch records and protocols. Show less

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  Farmson Pharmaceutical Guj Pvt Ltd

  Jan 2019 - Feb 2022

  Research Associate FDL

  • New Product Development. (Strategy planning, Execution & Co-ordination).• Responsible for QbD based product development of solid oral dosage forms for regulated markets.• Closely worked with technology transfer and commercial manufacturing teams for execution of products.• Responsible for training of technology transfer and commercial manufacturing team for specialized technology.• Responsible for generic product development for regulated markets for international clients and generic product portfolio.• Ensure complete, consistent, and comprehensive high-quality ANDA submission dossiers• Planning and Execution of Scale-up, Exhibit and R&D Validation Batches.• To approve the instructions relating to product operations including the in-process controls and to ensure their strict implementation.• Technical Support to R&D by identifying the critical process parameters, critical quality attributes for scale up and optimization of process in order to set formulations as per site.• Planning and Execution of Scale-up, Exhibit and validation batches.• To do and ensure the appropriate process validations and calibrations of control equipment’s areperformed and recorded and the reports made available.• Responsible for team management, including identifying training and development needs.• Scientific writing: protocols, SOPs, logbooks, project reports, analytical transfer methods, development reports.• Verify the availability of Raw Material / Packing Material and Tooling for new Products. Show less

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  SHIVAM PHARMACEUTICAL STUDIES & RESEARCH CENTER 282

  Mar 2022 - Aug 2022

  Assistant Professor

  • Primary responsibilities are classroom teaching of pharmaceutical Technology and pharmaceutics based projects to graduate and post graduate students.• Teaching to graduate students, teaching and research project supervision to graduate and Post-graduate Students • Teaching to graduate students on the theory and laboratory practicals on the courses related to Pharmaceutical Science and Medicinal Chemistry, Pharmacology, Pharmaceutical Quality Assurance. • Design and implementation of lesson plans of Pharmacy students • Design and implementation of Laboratory manuals• Organize and conduct laboratory experiments • Conduct lecture and exam schedules of theory and practical sessions• Conduct GTU external exam for graduate and post graduate students• Organized conferences, guest lectures, seminars or webinar and GTU activities. Show less

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  China Med Device

  Sept 2023 - Dec 2023

  Regulatory Affairs Intern (Medical Devices & IVD)-Capstone Project

  • Led the Regulatory team in developing and implementing regulatory strategies for general medical devices and IVD products, as well as overseeing the submission of regulatory study documents.• Conducted research on regulatory submission and maintenance requirements in the United States, European Union countries with CE marks, the United Kingdom, and Latin American countries for devices and IVDs.• Created a comparison table outlining key submission requirements (technical and clinical), fees, and methods. • Identified key maintenance and post-market requirements and highlighted future trends. • Prepared a summary of international harmonization efforts among these countries, identified key local advisory agencies or consultants, and provided an overview of key EU and US manufacturers' regulatory and clinical affairs infrastructures in the EU, UK, and USA compared to China Show less