Aug 2021 – Present · 4 yrs 9 mos · United States

Aug 2020 – Dec 2022 · 2 yrs 4 mos · Burlington, Massachusetts, United States

• Open Avenues is a non-profit organization working to educate traditionally underrepresented student populations in the U.S. and inspire careers in STEM, business, and entrepreneurship.
• As a Global Talent Fellow at Open Avenues Foundation, I develop and lead Clinical Trial Management projects, helping students gain skills that are valued in the industry.

Apr 2019 – Jul 2019 · 3 mos

• 1. Devised a Regulatory Strategy for a medical device for the Middle East and North African (MENA) region, accelerating the launch of the product.
• 2. Assessed additional market claims for the product in the MENA region.

Sep 2018 – Mar 2019 · 6 mos · Baltimore, Maryland

• Raw Material Management process improvement.
• 1. Generated a database and digitised all the paper records of Raw Material Receipt Inspection Form.
• 2. Tracked the trends of several key performance indicators (KPIs) using pivots in MS Excel and R Command.
• 3. This data is used for the company's new ERP system and streamlined the Raw Material Management Process, increasing efficiency by 20%.
• Quality Records - Search Database
• 1. Created a Change Control database in MS Access, to search old records by using different features like record initiator name, important dates of the record, status of the record.
• 2. This critical tool assists employees and reduced 70% of time consumed in verifying data with paper records, increasing efficiency.
• Internal Audit for Facilities & Engineering Department
• 1. Conducted a 3-day internal audit to evaluate and minimise discrepancies in the department's data records and logs, Blue Mountain workflow management software.
• 2. Reviewed training records of employees, department SOPs and made recommendations for improvement.
• 3. Drafted an audit report highlighting major observations and suggestions to ensure GMP compliance.
• Client Audit Observation Analysis, Deviation procedures training
• 1. FDA regulations compliance was ensured by CAPA implementation for GMP processes on the basis of client observation analysis.
• 2. Trained on writing extensions for Change Controls and CAPAs in order to GMP compliance.
• 3. Trained on Deviation writing as per company's internal policies.

Jul 2018 – Aug 2018 · 1 mo · Greater Boston Area, New York

• 1. Devised and reviewed Lilu's practices for its massage bra medical device to verify conformance with GMP standards as mentioned in QSR (21 CFR 820).
• 2. Evaluated Product Registration and Device Listing Requirements (21 CFR 807) as supporting material for a pre-submission meeting with US-FDA
• 3. Developed a package insert and product label in accordance to 21 CFR 801 for a 510(k) submission.
• 4. Confirmed Class I classification of the product with FDA.

Jan 2018 – Jul 2018 · 6 mos · Greater Boston Area

• 1. Troubleshoot technical issues of Northeastern staff and students using 'ServiceNow' ticket management system.
• 2. Managed the electronic inventory and maintained a lab of 100-120 computer systems.

Jul 2016 – Jun 2017 · 11 mos · Mumbai

• 1. The Chemical Web, is a group which aims to connect students with the alumni of ICT to understand the fast growing chemical industry and also help students build their overall personality and inculcate entrepreneurial skills to become pioneers in the field of Chemical Engineering & Technology.
• 2. Led a group of 30 enthusiastic students to organise several personality developments workshops at the Institute of Chemical Technology.
• 3. Conducted 6 Industrial visits to various chemical industries around Mumbai, India which gave the opportunity to 200 freshman and sophomore year students at the Institute of Chemical Technology to see functioning chemical plants first hand and understand various large scale processes.
• 4. Organised a 2-day Matlab workshop to enhance software skills of more than 150 Chemical Engineering and Technology undergraduate students.
• 5. Managed a 2-day soft skills workshop focused on improving the overall personality of 200 students at Institute of Chemical Technology.

Sep 2015 – Jul 2016 · 10 mos · Mumbai

May 2016 – Jul 2016 · 2 mos · Navi Mumbai, India

• 1. Facilitated the Quality Assurance team in maintaining records, SOPs, analysing recalls and developing CAPAs
• 2. Comprehended various ICH guidelines and FDA guidance documents
• 3. Underwent practical manufacturing training of an API and parenteral plant

Sep 2015 – Jan 2016 · 4 mos · Mumbai

• 1. Campus Ambassador of Internshala at the Institute of Chemical Technology.
• 2. Marketed the products and services of Internshala on various social media platforms and offline.
• 3. Winner of one of the programs conducted during the internship to increase the sales of the products and services on digital platforms like Facebook.

Jun 2015 – Jul 2015 · 1 mo · Mumbai Area, India

• 1. Aided with the analytical testing of solid dosage forms like Dissolution testing, Disintegration Time, Karl Fischer Titration etc. at pilot scale.
• 2. Comprehended the functioning of HotMelt Extrusion technique to enhance drug solubility.
• 3. Assisted in formulating tablets using Direct Compression Process.