Biologe (m/w/d)
Core
Planning, conducting, and follow-up of national and international GMP audits for suppliers and service providers in the pharmaceutical industry.
Role type
Senior GMP Auditor (Pharmaceuticals)
Builds
Audit reports and compliance assessments for suppliers and service providers
Domain
Pharmaceutical industry, Quality Assurance, GMP compliance
Required skills
GMP regulations knowledge, international regulatory authority experience, supplier audit management, inspection readiness support, strategic project participation
Preferred skills
Experience as GMP Lead Auditor, experience in active pharmaceutical ingredient manufacturing, aseptic or biotechnological drug production, qualification and validation experience
Technologies
GMP regulatory frameworks
Responsibilities
Plan, conduct, and follow up on national and international GMP audits for suppliers and service providers; Support and train auditors and accompany regulatory inspections; Advise production sites on inspection preparation; Participate in strategic projects such as product development, second sourcing, and international market access
Seniority
Senior, hands-on IC
