Compliance Lead Auditor for Pharmaceutical and Medical Device Industries

vor 2 Wochen


Köln, Nordrhein-Westfalen, Deutschland Planet Pharma Vollzeit

At Planet Pharma, we're seeking a skilled Compliance Lead Auditor to join our team. As a senior-level auditor, you'll be responsible for leading the supplier qualification process and managing initiatives to complete requirements audits.

About the Role

This is a unique opportunity to leverage your expertise in GMP auditing, quality management, and regulatory compliance. You'll work closely with our QA department to develop audit evaluation strategies, identify weaknesses, and recommend corrective actions.

The ideal candidate will have experience in the pharmaceutical, medical device, or biologics industry, with a strong background in auditing production facilities and laboratories. Proficiency in Microsoft Office and eQMS software, such as TrackWise, JDE, or Veeva, is also required.

Key Responsibilities
  • Lead supplier qualification processes and manage initiatives to complete requirements audits
  • Develop audit evaluation strategies, identify weaknesses, and recommend corrective actions
  • Evaluate supplier responses to corrective and preventive actions related to audit findings
  • Assist in reviewing supplier requirements by obtaining quality requirements and solutions for areas identified as compliance issues
Requirements

To succeed in this role, you'll need:

  • GMP Auditing experience
  • Experience in the pharmaceutical, medical device, combination product, and/or biologics industry (desirable)
  • IT skills in Microsoft Office and eQMS software
  • Knowledge of pharmaceutical regulations and international standards for aseptic manufacturing
  • Project management skills

We offer a competitive salary range: $110,000 - $140,000 per annum, depending on qualifications and experience.



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