Harshit Dave

Experience

• 

  Zydus Group

  Jul 2014 - Jul 2018

  • Providing analytical inputs to the core product development team for solid oral dosage forms - Research and marketing side• Responsible for conduction and reporting of specific tests for developmental batches - Assay, Dissolution and Related Substance tests (RS)• Specialised function on stability protocol for the developmental batches• Front facing role on deficiency and query response to the regulatory and certifying authorities• Co-ordination with the formulation and development department for regular and developmental batches being processed at the manufacturing unit• Providing analytical inputs to the core product development team - Research and marketing side• Specialised function on stability protocol for the developmental batches• Front facing role on deficiency and query response to the regulatory and certifying authorities• Compiling, ratifying and curating the data generated from tests in an orderly & accessible manner Show less • Imparted industrial learning experiences in the pharmaceutical analysis field - focus on practical learning on various systems and methodologies• Rigorous training on guidelines and SOPs regarding development and validation of multiple product lines. Specialised in for solid oral dosage forms.• Hands on experience for instrument learning - Dissolution Apparatus USP (1, 2 & 3), HPLC, IR, FT-IR, UV• Usage and projects on analytical softwares to develop competence - Chromeleon 7.2 (Chromatography Data Systems), Empower 3, Camstation and ClassVP Show less

  • Senior Executive - Analytical Development

    Apr 2016 - Jul 2018

  • Officer - Analytical Development

    Jul 2014 - Apr 2016
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  Earth5R

  Dec 2015 - Dec 2016

  Social Entrepreneurship Intern

  • Ran a long campaign on the proper cleaning methodology for vegetables and fruits to ensure minimum pesticide load in consumed meals - backed with research data from prior research at university• Initiated waste management awareness in the community and social circle - Educated on the issues of organic waste and plastic waste• Organised and conducted cleanliness drives across the district of Gandhinagar• Propounded the detrimental effects of lack of vigilance towards environmental issues; with a focus on the Green Citizen's Model Show less

• 

  Contract Pharmacal Corp

  Aug 2018 - May 2020

  Research Scientist - II
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  Torrent Pharmaceuticals Ltd

  Jun 2020 - Nov 2022

  Scientist II

  • Providing analytical inputs to the core product development team for solid oral dosage forms• Responsible for conduction and reporting of specific tests for developmental batches - Assay, Dissolution and Related Substance tests (RS)• Specialised function on stability protocol for the developmental batches• Front facing role on deficiency and query response to the regulatory and certifying authorities• Co-ordination with the formulation and development department for regular and developmental batches being processed at the manufacturing unit• Providing analytical inputs to the core product development team• Specialised function on stability protocol for the developmental batches• Front facing role on deficiency and query response to the regulatory and certifying authorities• Compiling, ratifying and curating the data generated from tests in an orderly & accessible manner Show less

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  JAMP Pharma Group

  Dec 2022 - now

  Technical Documentation Specialist(Sr. Exe.)

  Leading cross-functional teams to achieve project milestones and deadlines effectively.Conducting regular communications and meetings to ensure project alignment and progress.Coordinating project life cycles with cross-functional teams, including Product Development and Regulatory Affairs.Ensuring timely project submission through effective collaboration with CMO and other teams.Managed analytical project activities, ensuring timely and efficient project execution.Preparation of Statement of work and other documents for CMO, CDMO and other partners. Show less