Quality Assurance Manager for Analytical Method Validation

vor 4 Wochen

Darmstadt, Hessen, Deutschland Bayer Vollzeit

At Bayer, we're driven to solve the world's toughest challenges and strive for a world where health for all and hunger for none is no longer a dream, but a real possibility.

As a QA Manager for QC Oversight and Change Management, you will play a crucial role in ensuring the quality and compliance of our laboratory operations.

Your Key Responsibilities:

  • Secure QA monitoring for the validation of analytical methods
  • Ensure regulatory requirements and their implementation in the laboratory area
  • Review and approve SOPs and quality control qualification documents
  • Review and approve deviations, out-of-specification (OOS), CAPAs, and quality control changes
  • Represent quality assurance in cross-functional teams and projects

In the field of change management:

You will provide support in coordinating approval and implementation of change projects across the site.

Requirements:

  • University degree in a natural sciences degree program
  • Several years of professional experience in the GMP-regulated area, preferably in a role in the field of quality
  • High degree of accuracy in dealing with national and international regulations (GMP, ICH, EMA)
  • Excellent communication and analytical skills as well as a high level of quality awareness, proactivity, and reliability
  • Good (cross-functional) teamwork skills
  • Very good written and spoken German and English skills

What We Offer:

  • Competitive compensation package
  • Flexible work models and part-time arrangements
  • Family-friendly benefits, including company daycare centers and support in finding childcare
  • Professional growth opportunities through training programs and development dialogues
  • Health awareness and opportunities for self-care
  • Inclusive work environment that welcomes and supports diversity

This position is limited to 9 months as a parental leave replacement.

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