Ankit Rathi

Background

About Ankit Rathi

Analytical self-starter with a strong attention to detail. Effective presentation, communication, and interpersonal skills combined with a passion for Life Sciences. Broad operations experience in Project Management, Regulatory Affairs, Analytics, and Quality Initiatives within the Life science and consulting space. Key skills: GMP compliance for 21 CFR Part 110, 21 CFR Part and 21 CFR Part 117, HACCP, FSMA, PCQI, FSVP, ISO, GFSI and NSF standards. Lab skills: Enzymatic assays, HPLC, ICP, qPCR and USP, FCC method developments. Summary of achievements- 1. Trained PCQI professional, executed compliance for 21 CFR Part 117. Faced 2 US FDA audits in Dec 2016 and Jan 2017 Result: No observations, no 483's issued. Faced and successfully completed GMP certification from external certification agency. Successfully Faced total of 12 audits from customers, KOSHER, HALAL, CA State FDA, US FDA and county inspections. Developed and implemented HACCP plan for food manufacturing policy. Certified food safety professional with HACCP, advanced HACCP, PCQI, FSMA, FSVP certifications 7. Created 6 Drug Master Files (DMF) for registration of product in US, Europe, Canada, Australia and latin american countries 8. Developed product registration documents for animal feed enzymes and successfully 6 products for animal feed across 6 states in USA and 12 countries worldwide 9. Installed and validated ICP, enzymatic assay as per USP, FCC standards; Blender validation, cleaning validation, allergen cleaning validation and process validation 10. Trained and Led team of 4 for GMP compliance for 21 CFR Part 110, Part and Part 117 compliance 11. Completed over 50+ training sessions of over 40 employees 12. Presented 5 talks for university students across USA and India