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Jessica Siefert

About Jessica Siefert

Senior Consultant, (GMP-) Auditor und Trainerin

 

  • Expertise in Projekt- und Programmmanagement
  • Qualitätssicherung und Datenintegrität
  • Vorbereitung auf Zertifizierungen und Akkreditierungen
  • Prozessoptimierung nach globalen/regulatorischen Standards
  • Vertraut mit European Directive/Regulation EU, FDA 21 CFR part 11, ISO 13485, HACCP, IFS, ISO 9001, ISO 19011, ISO 27001, ISO 17067, ISO 17029

 

Branchenschwerpunkte: Pharma, Food & Beverage

Entries by Jessica Siefert

GMP

Supplier management in the GMP industry: regulatory framework and qualification

Effective supplier management in the GMP sector is more than just an operational purchasing process. In highly regulated environments such as pharmaceuticals, biotechnology or active ingredient manufacturing, the systematic qualification and monitoring of suppliers is crucial for product quality, patient safety and regulatory compliance. With the increasing global networking of supply chains and growing inspection […]

2 weeks /by Jessica Siefert
GMP

Mastering GMP audits successfully: What really matters

GMP audits are one of the key quality assurance tools in the pharmaceutical and life science industry. They check whether manufacturing processes, documentation, systems and working methods comply with regulatory requirements at all times. This is not just about compliance with formal requirements, but also about ensuring product safety, process stability and quality in practice. […]

18. November 2025/by Jessica Siefert
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