Quality assurance specialist (m/f/d) 100%

• Evaluate and authorize master batch records while ensuring full compliance with regulatory standards and internal procedures
• Oversee deviation management processes, handling both routine and complex quality issues with precision
• Facilitate analytical and process modifications by supporting change request evaluations and implementations
• Coordinate sample management activities including retention sample maintenance and international shipment logistics under quarantine protocols
• Lead validation initiatives through comprehensive process validation support and technical transfer report approvals
• Conduct regulatory assessments including pre-PAI evaluations and documentation support for filing submissions
• Maintain external partnerships through regular site visits and relationship building with manufacturing partners

• Advanced problem-solving capabilities with ability to develop innovative solutions for complex pharmaceutical challenges
• Independent work style with minimal supervision requirements and strong self-direction skills
• Subject matter expertise serving as a resource and mentor for colleagues in quality assurance disciplines
• Leadership experience in team or project management roles with proven coaching abilities
• Cross-functional collaboration skills with demonstrated interpersonal and relationship-building strengths
• External manufacturing knowledge including supply chain and operational expertise
• Language proficiency in English (fluent) with German language skills highly advantageous
• Pharmaceutical industry background with comprehensive understanding of Quality Systems, GMP, and regulatory requirements

• Nemensis AG is your specialised recruitment partner in Life Sciences, based in Basel
• Comprehensive support and guidance throughout the application process
• Access to a broad network of clients and exciting opportunities in Northwestern Switzerland
• Fast and seamless entry with personalised assistance

Nemensis