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

By /
  • 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

Apply Now

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

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