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Compliance Specialist

vor 2 Monaten

Penzberg, Bayern, Deutschland GULP – experts united Vollzeit

About GULP – experts united

We are a leading provider of expert services in the pharmaceutical industry, and we are seeking a highly skilled Compliance Specialist to join our team.

Job Summary

The Compliance Specialist will be responsible for ensuring the GxP compliance of all activities in the clinical trial supply management, drug-related distribution, and storage.

Key Responsibilities

  • Support the development and implementation of GxP compliance strategies and procedures
  • Ensure the maintenance of accurate and up-to-date GxP documentation and records
  • Provide operational support and independent performance of operational tasks as a process expert in the IMP GxP Compliance Team
  • Establish and maintain inspection readiness for clinical trial supply activities and support in preparing, accompanying, and following up on audits and inspections
  • Optimize processes and workflows to ensure compliance with regulatory requirements

Requirements

  • Completed university degree or a similar education with a scientific focus
  • Several years of work experience in the pharmaceutical or biotech industry
  • Knowledge of quality standards (GMP, GCP, GDP) and regulatory requirements in an international environment
  • Proficient skills in the use of MS Office applications and a quality management system
  • Strong communications skills, good German language skills, and fluency in English