Deviation & Capa Manager(m/w/x)

Anforderungen

• Bachelor’s or Master’s degree in Logistics Engineering, Engineering, Material Management, Hygiene, or related field
• Minimum of 5 years of experience in GMP-regulated biopharmaceutical or manufacturing environment
• Strong knowledge of deviation management and CAPA processes
• Experience with Quality Management Systems (e.g., TrackWise, LIMS, etc.) preferred
• High level of technical understanding and ability to interpret complex processes and systems
• Ability to work independently and manage responsibilities with minimal reliance on subject matter experts
• Strong analytical and problem-solving skills
• Fluency in German or English; bilingual proficiency is a plus

Aufgaben

• Manage and evaluate deviations in logistics and hygiene areas for MC1 and MC2
• Prepare, review, and maintain GMP documentation, including Deviation Reports, CAPAs, SOPs, and Risk Assessments
• Develop, review, and implement process-related procedures such as Standard Operating Procedures and risk analyses
• Prepare, update, and monitor cleaning plans in logistics and hygiene areas
• Manage interfaces between Logistics, Clean Utilities, Industrial Hygiene, QA, QC Monitoring, Facilities, and Production
• Ensure correct implementation, documentation, and approval of all GMP-related technical requirements
• Support the preparation and review of GMP documentation and Change Requests for MC1 and MC2
• Provide expert advice for cross-functional investigations related to logistics and hygiene processes
• Conduct regular on-site inspections to identify potential risks and improvement opportunities
• Execute CAPA actions and ensure timely follow-up and closure within the Quality Management System
• Collaborate with cross-functional teams to address and resolve quality issues
• Identify trends and propose recommendations for process optimization and quality enhancement
• Support internal and external audits and regulatory inspections

Berufserfahrung

Ausbildung

Sprachen

Tools & Technologien