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RA/QA Operations Specialist

Company

Zentiva Group, a.s.

Location

India, India

Posted

June 24, 2026

Position Overview

MISSION STATEMENT

Main Job Purpose:

The RA/QA Operations Specialist supports the Responsible Person (FvP) in ensuring full compliance with Swissmedic, GMP and GDP requirements for all regulated activities related to import, distribution, release and lifecycle management of medicinal products in Switzerland.

The role combines operational Regulatory Affairs and Quality responsibilities, ensuring product quality, regulatory compliance and patient safety across the entire product lifecycle.

MAIN ACCOUNTABILITIES AND DUTIES

Quality system management

  • Support implementation and maintenance of the local Quality Management System in line with Swissmedic, GMP and GDP requirements
  • Ensure compliance with internal procedures and regulatory standards for all GxP-relevant activities
  • Support inspection readiness and participate in internal audits and health authority inspections
  • Create, review and manage SOPs and qua...
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