πŸ‡ΊπŸ‡Έ USAJobs.work

America's Job Portal

← Back to USA Jobs

Site Quality Head (DGM/GM)- API Site

Company

Confidential

Location

India, Maharashtra

Posted

June 20, 2026

Position Overview



Key Responsibilities:



  • Lead and oversee Quality Assurance (QA) and Quality Control (QC) functions at the API manufacturing facility.

  • Ensure compliance with cGMP, ICH, WHO, USFDA, and other international regulatory standards.

  • Manage Quality Systems — change control, deviation, CAPA, OOS/OOT, investigations, and document control.

  • Review and approve SOPs, specifications, validation protocols, and batch manufacturing records.

  • Coordinate internal audits, vendor audits, and regulatory inspections; ensure timely closure of audit observations.

  • Oversee product release and ensure all quality parameters meet regulatory and customer requirements.

  • Drive continuous improvement initiatives in quality systems and manufacturing processes.

  • Train and mentor QA/QC teams to enhance compliance culture across the organization.

  • Liaise with regulatory au...

Ready to Apply?

Join thousands of Americans building their careers

Apply Now