Siddhant Koyate

Experience

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  Child care hospital Pune

  Jun 2019 - Jul 2019

  Hospital pharmacy intern

  ·Communicated with patients and assisted with dispensing prescription drugs by reviewing safety guidelines and protocols.·Maintained inventory of drugs, and supplies and ·Reviewed and archived detailed records of office inventories.·Provided consultation to patients of all ages from pediatric to geriatric about potential issues and reactions to specific medications.

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  Northeastern University

  Sept 2022 - Mar 2024

  • Addressed student concerns by liaising with cross-functional teams, working collaboratively to devise solutions for residential issues.• Implemented efficient station coverage supervision to maintain operational effectiveness.• Expertly managing lockout scenarios in residential buildings, ensuring minimal disruptions and optimizing resident satisfaction levels.• Meticulously documenting incidents through dispatch logs and Excel sheets, guaranteeing precise records and expediting responses to security issues.• Leveraging SharePoint to enhance document sharing and team collaboration, fostering efficient communication and fortifying a cohesive team environment.• Trained proctors to troubleshoot technical problems, and clarified policies to prepare for foreseeable situation. Show less

  • Resident Student Shadow Supervisor- Residential Security Office (RSO)

    Sept 2023 - Mar 2024

  • Global Student Mentor

    Sept 2022 - Sept 2023
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  Akston Biosciences Corporation

  Apr 2023 - Sept 2023

  Quality assurance and documentation control Intern

  • Conducted operational review of the executed Batch Records, analytical raw data, assay records, material specifications, certification of analysis, certificate of calibration, area cleaning, pest control, and EM report for their completeness and compliance with GDP• Supported management with Client audits and inspections, as a runner for document handling and led in the development, review, approval, and submission of responses to cited observations and deficiencies along with tracking of reports on commitment status through closure• Assisted in conducting internal audits of manufacturing units and analytical laboratories to ensure regulatory and quality compliance• Issued Controlled documents such as logbooks, deviation forms, CAPA forms, and change control forms along with assigning Document Control numbers and Controlled Copy Numbers to forms and other documents • Handled Standard Operating Procedures (SOP) related change controls for all departments of the plant. Maintained deviation, CAPA, and Change Control log by assigning new control numbers, tracked ongoing investigations for timely closures and timeline extensions.• Participated in the execution of investigation and root cause analysis for nonconformance during the raw material release and approved label inventories• Created a document management tracker using Smartsheet as part of document management and control strategy in the quality management system thereby saving time and reducing the cost of scanning and archiving documents by 90 percent• Supported execution of GMP training and maintained training records of departments involved in GMP activities at the manufacturing site Show less

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  Intuvie

  Jan 2024 - Apr 2024

  Regulatory & Quality Intern (Capstone Project)

  - Performed regulatory evaluation of medical device labeling and promotional procedures (SOPs and Work Instructions) against the FDA and RoW regulations on labeling and promotion. - Additionally provided back-room assistance in preparation of regulatory and quality system documentation in preparation for internal and external audits.