Compliance officer

6 hours ago


India Bridge Health Full time

Position: Compliance Officer – US Market Location: Remote — must maintain at least 3 hours daily overlap with U. S. Eastern Time (GMT-4/-5) Type: Contract About the Company Bridge Business Support Services is leading the delivery of a cutting-edge, FDA-c GMP artemisinin manufacturing line -combining continuous photochemistry, crystallization, and solvent recovery at industrial scale. Responsibilities: Ensure all engineering, procurement, and pilot operations comply with US FDA c GMP, 21 CFR Part 11, ICH guidelines. Develop and maintain compliance frameworks for documentation, vendor qualification, audits. Review engineering documents (PFDs, P& IDs, equipment datasheets) for regulatory alignment. Prepare and support qualification protocols (IQ/OQ/PQ) for equipment and systems. Coordinate with vendors and internal teams to ensure regulatory-ready procurement & installation. Support preparation of regulatory submissions (DMFs, CMC sections). Conduct internal audits and prepare teams for external audits (FDA, clients). Qualifications & Skills: B. E./B. Tech (Chemical/Pharma/Mechanical/Instrumentation) or M. Pharm with compliance specialization. 6–8 years’ experience in pharma/biotech compliance (regulatory, QA, or engineering compliance). Strong knowledge of US FDA, ICH, EMA regulatory frameworks. Experience in equipment qualification, vendor audits, GMP documentation. What We Offer Salary paid in USD Remote work flexibility Performance-based bonuses and growth opportunities Collaborative, startup-style work environment Access to learning, tools, and mentorship to boost your career


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