Beschreibung

In this role, you will oversee the management of deviations and CAPA processes, ensuring compliance with GMP standards while driving continuous improvement in logistics and hygiene. Your day-to-day responsibilities will involve collaborating with various teams, conducting inspections, and optimizing quality systems.

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

Tools & Technologien

Benefits