Arisha Ali

Experience

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  Windsor Mountain International Summer Camp

  Jun 2019 - Sept 2019

  Camp Counsellor

  -Working with other camp staff members to plan, coordinate and lead camp events.-Leading and supporting campers as they participate in age-appropriate activities.-Monitoring campers to ensure compliance with camp rules and prevent accidents.-Memorizing all emergency procedures and enforcing camp rules.

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  UCD Foundation

  Jan 2020 - Jun 2021

  Fundraising Student Caller

  -Conducting phone calls with alumni professionally, surveying them on their time in UCD and fundraising for the UCD Champion Alumni Fund-Providing alumni with the organization’s services and fundraising information.-Processing forms, donations and applications from the alumni over the phone

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  University College Dublin

  Jun 2020 - Sept 2020

  Student Researcher

  -Researching and developing a programme which filtered various databases containinginformation on the genetics of bacteria.-Creating a command-line tool using Python to allow users to search through several genetic databases -Pushing and sharing the programme using Git.-Creating a poster and presenting my project to adjudicators

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  Optum

  Jun 2021 - Aug 2021

  Technology Development Intern

  -Creating a web application which brings together 4 micro-services and presents healthcare provider information-Working in a fast paced environment with a team of 6 people to create a web-applications which functions as a search engine for healthcare provider data-Learning new technologies (namely Java, Springboot and Thymeleaf) quickly and effectively to meet deadlines-Presenting my project updates at biweekly 'Shark Tanks', company-wide Connect forums with almost 1000 attendees and at a final presentation event with judges Show less

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  University College Dublin

  Aug 2021 - Jul 2023

  Residential Assistant

  -Managing a university residence of over 300 diverse students in a team consisting of 2 residential assistants and 2 security officers-Responding to questions, enforcing residence rules and reacting to emergencies during a 10-15 hour working week and overnight. -Organising events and engagement clubs across campus to create a sense of community across the residences.

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  Accenture

  May 2022 - Aug 2022

  Consulting Development Intern

  - Professional project management experience. Managed the portfolio and pipeline of projects used by a large, multi department social science research-engagement team using Coda, a project management information system. - Analysed and documented client business processes, market dynamics and corporate strategy to assist in the translation of research into client experiences and strategies for sustainability, trustworthy technology and virtual reality- Produced high quality, comprehensive technical reports, including quarterly summaries, client output presentations, and client business cases using MS Word or Powerpoint, which effectively communicated the tangible benefits of the research-engagement team’s work to clients through compelling storytelling- Conducted quality assurance on various technical outputs (AI models, virtual reality landscapes, etc) using Python and MS Excel to ensure accuracy and comprehensive coverage of client use cases. Show less

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  EIT Manufacturing

  Sept 2022 - Nov 2023

  Teaching Assistant

  Course content focused on the development of sustainable business models, circular design thinking, ESG reporting and the current European regulatory environment. - Facilitated 200+ students and 10 teams to develop entrepreneurship projects incorporating ML/AI for greenhouse gas (GHG) emission predictions to support businesses with ESG regulations. - Provided regular feedback and support with ideation, product development and customer discovery activities (interviews)- Supported lead lecturer in the development of learning modules, assignments and in-class activities focused on entrepreneurship ethics, ideation, customer discovery, customer segmentation and competitor analysis Show less

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  Health Products Regulatory Authority (HPRA)

  Jan 2024 - now

  - Reviewing signals and reports of potential, pending and current medicine shortages received from multiple stakeholders, such as the pharmaceutical industry (including wholesalers), healthcare professionals and patients, to identify where actions are required. - Analyzing shortages and market share data to determine the patient impact of a medicine shortage - Developing and Implementing preventative measures to reduce the likelihood of medicines shortages occurring and optimising the current shortages framework- Developing expertise and analyzing the industrial and market aspects of the pharmaceutical sector, including on the functioning of the medicines supply chains and the pricing, reimbursement and procurement mechanisms.- Arranging for the communication of information in relation to medicine shortages to stakeholders, such as healthcare professional and patients- Assisting in the management of the HPRA Exempt Medicinal Product Notification System to ensure that all wholesalers or manufacturers bringing such products into Ireland for supply on the Irish market are notifying receipt of EMPs correctly. This involves liaising closely with such wholesalers to set up such notification accounts and dealing with any problems with product information notified as they arise.- Analysing EMP notification data to understand the usage of EMPs in Ireland and the factors that may lead to fewer EMPs being required- Representing the HPRA in initiatives to manage and prevent shortages at an EU and global level Show less - Assessed new applications and variations for regulatory filing from pharmaceutical and medical device companies to ensure compliance with Good Manufacturing Practices (GMP) and adherence to safety and quality standards according to the Medicinal Products (Control of manufacture) Regulations 2007 and EU Directives: 2001/83/EC, 2001/82/EC, 2001/20/EC- Collaborated with representatives from European regulatory authorities to collate data on potential medicine shortages across the EU and EEA in cases of GMP non-compliance- Analysed and visualised medicine shortage data from across the EEA using Python (Pandas library) and Excel.- Presented medicine shortage data in an interpretable form to EEA competent authorities, informing decision-makers on potential shortages resulting from GMP non-compliance.- Proposed and implemented preventative and corrective measures to prevent unnecessary time delays in the regulatory filing process using Lean methodologies (root cause analysis)- Maintained the quality management systems for licensing and inspection activities by updating SOP documentation and work instructions during process updates and technology transfer- Analysed common mistakes made by pharmaceutical companies in the manufacturing authorization applications to identify shortfalls in official guidance documents. Updated guidance documents to streamline the application process for stakeholders - Communicated with stakeholders including regulatory staff at pharmaceutical companies, other National Competent Authorities in the EEA, the American FDA, and Health Canada- Supported inspectors with scientific and technical guidance during preparation and follow-up of manufacturing site inspections- Issued GMP certificates and manufacturing authorisations to compliant organisations using the EUdra database established by the European Medicines Agency. Show less

  • Scientific Officer (Medicine Shortages)

    Oct 2024 - now

  • Scientific Officer (Regulatory Compliance)

    Jan 2024 - now