Quality Auditor – Pharmacovigilance (GVP) – Competitive Salary & Benefits

Merck KGaA Jobs
  • Merck KGaA
  • Darmstadt, Hesse, Germany
  • Full-time

About the Role

Do you have a passion for quality and a keen eye for detail? Are you eager to make a real difference in the world of pharmaceuticals? If so, then we invite you to join our very engaged quality auditing team at Merck KGaA!

As a Quality Auditor, you will play a crucial role in ensuring the safety and efficacy of our pharmaceutical products. You will lead and participate in a variety of audits, including on-site and remote subsidiary/affiliate audits, vendor audits, process audits, and business partner audits. Your responsibilities will include:

  • Performing data analytics to prepare for audits
  • Creating standardized audit plans
  • Generating comprehensive audit reports
  • Presenting audit observations and following up on corrective actions
  • Contributing to the continuous improvement of our quality auditing function
  • Supporting the Inspection Management Team in preparing for and hosting inspections

Who You Are

  • You have at least 3-5 years of experience in pharmacovigilance quality management and/or systems auditing.
  • You possess a strong understanding of Quality Assurance principles and auditing skills.
  • You are knowledgeable about GVP, ICH, US FDA, and EMA regulations.
  • You are a highly organized and structured individual with excellent project management skills.
  • You are a team player with exceptional communication and intercultural skills.
  • You are proficient in PowerBI, MS Office 365, and Veeva Vault QMS.
  • You have excellent oral and written communication skills in English, and ideally one other language (Chinese or Spanish preferred).
  • You are willing to travel globally (up to 15% of the time).

What We Offer

If you are a highly motivated and self-starting individual who is passionate about quality, then we encourage you to apply for this exciting opportunity!

To Apply

To view more open positions kindly visit Merck KGaA career website.

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