Company Description: Nthra Labs (www.nthralabs.com) is building conformance infrastructure that helps manufacturers in regulated industries validate incoming and outgoing materials with verifiable proofs. A core part of this is turning product and material specifications, along with regulations, into a set of rules that machines can comprehend.
About the work: We're looking for experts who have experience working with regulations and material conformance in EV Batteries & Pharma manufacturing— someone who can help us convert a set of standards into rules for a few chosen materials, for Indian manufacturers who export to the US and Europe. This is a short, outcome-based engagement. You are not managing a team.
You are the person who knows exactly what "meets the standard" means for each material, and you help us write that down in a form a machine can check.
Take the US FDA and USP standards /EU Battery Regulations that apply to chosen materials and break each one into small, testable rules
Review the logic our team encodes to confirm it matches what the regulation actually intends.
What we are looking for: Pharma
Hands-on QA, QC, or regulatory experience at an Indian pharma manufacturer (formulation or API) that exports to the US.
Solid working knowledge of US FDA cGMP (21 CFR 210/211), USP monographs, and Certificate of Analysis/specification review. EV Battery
Hands-on experience in battery quality, testing, homologation, or regulatory work at a cell maker, pack assembler, or EV OEM. Working knowledge of the EU Battery Regulation and the coming Digital Battery Passport.
Comfortable working closely with a technical team in plain language