Compliance Officer – US Market
4 days ago
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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