Sahil Kishor Butala
Quality Assurance Compliance Specialist- II @ FDBT | Validation Engineer Co-Op at Catalent Pharma | M.S. in Regulatory Affairs, Northeastern University, Boston, US |
- Role
- Quality Assurance Compliance Specialist- Ii at FUJIFILM Biotechnologies
- Location
- Bryan, TX, US
- LinkedIn followers
- 500 followers
About Sahil Kishor Butala
I am an aspiring individual pursuing MS in Regulatory Affairs at Northeastern University, Boston campus. Seeking co-op and internship opportunities for the summer of 2023. Completed Master of Pharmacy with a specialisation in Quality Assurance. Have four years of working experience at the pharmaceutical R&D center in the department of Quality Assurance.During years of service got well acquainted to regulatory requirements through the audits by regulatory bodies. I have been a part of the regulatory strategy team and would like to take a deeper dive into it. Well versed with good documentation practices and ICH guidelines. Proficient in MS office, MS word, MS excel, Adobe Acrobat. Looking forward to learning regulatory norms, understanding requirements for filing new products into the market, making regulatory strategies, and knowing the work culture in the US.
Experience
Quality Assurance Compliance Specialist- Ii
May 2025 — Present · TX, US
Supporting site readiness for regulatory inspections, ensuring alignment with applicable global regulatory standards (e.g, FDA, EMA), and contributing to continuous compliance efforts.Providing QA support during client audits and regulatory inspections, evaluating systems and processes for suitability, effectiveness, and compliance, aligning with regulatory expectations.Executing audit strategies and leading internal process audits, ensuring continuous monitoring and assessment of quality systems as per regulatory requirements.
Education
SVKM's Bhanuben Nanavati College of Pharmacy
Master of Pharmacy, Pharmacy, Quality Assurance
2016 — 2018
Mumbai Educational Trust, MET League of Colleges
Bachleor of Pharmacy, Pharmacy
2012 — 2016
Northeastern University
Master's degree, Regulatory Affairs
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