GDP Operations Specialist H/F

Introduction

Description de la mission

• Lead Change Control processes and QMS activities.
• Conduct investigations for deviations and identify root causes.
• Prepare, update, and approve procedures in compliance with GMP/GDP requirements.

• Support internal audits, health authority inspections, and supply chain projects.
• Compile performance metrics and manage documentation according to record management and data integrity standards.
• Ensure timely progress and closure of CAPAs and other corrective actions.

• Drive local initiatives to enhance compliance and reduce costs.
• Conduct technical assessments and risk analyses, including for contracted activities impacting GDP.

Profil attendu

• 5-8 years in a quality or compliance role in the pharmaceutical industry, with a strong focus on GDP.
• Deep understanding of pharmaceutical legislation and GDP practices.

• Excellent interpersonal and communication skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Results-driven, adaptable, and able to thrive in a fast-paced environment.
• Formal GDP certification and proven ability to apply international regulations.