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Compliance Officer – US Market
Bridge HealthBelgaum, IN1 day ago
Job descriptionB.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. 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
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-cGMP 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 cGMP, 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 :
What We Offer
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Compliance Officer • Belgaum, IN