Compliance Officer – US Market

4 weeks ago

Solapur, 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-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:

  • 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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