Qa Specialist

Zentiva Group, a.s

Switzerland
Gmp/gdp regulatory compliance knowledge
Swissmedic regulation expertise
Batch documentation evaluation skills
The role is responsible for implementing and maintaining a local quality system specifically for SwissMedic-regulated activities

Job Summary

  • The role is responsible for implementing and maintaining a local quality system specifically for SwissMedic-regulated activities.
  • Candidates must manage product-related deviations, complaints, and CAPAs while ensuring patient safety and product quality.
  • The position involves preparing market releases for purchased or repacked products and evaluating certificates of analysis.

Matching Summary

The role is responsible for implementing and maintaining a local quality system specifically for SwissMedic-regulated activities.

Skills & Requirements

Must-have

  • GMP/GDP regulatory compliance knowledge
  • SwissMedic regulation expertise
  • Batch documentation evaluation skills
  • CAPA management experience
  • eDMS document management proficiency

Nice-to-have

  • Fiori Product Quality Management system
  • Internal audit participation experience
  • Temperature excursion management
  • Training employee on quality systems
  • Product database maintenance skills

Key Requirements

  • Experience with GxP regulated activities
  • Knowledge of international GDP/GMP requirements
  • Ability to write and manage SOPs
  • Proficiency in electronic Document Management Systems
  • Understanding of Swiss local regulations

Work Rights

Not specified

Tailored Resume

Cover Letter