Bachem AG
QA Shopfloor Manager
📍 4416 Bubendorf
Role and responsibilities
Provide proactive quality presence on the shopfloor to ensure uninterrupted, compliant manufacturing operations and meeting adherence to schedule Act as the primary QA point of contact for production teams enabling fast, informed decision-making and real-time issue resolution Ensure seamless QA support by coordinating across QA functions to deliver consistent, and efficient quality support to manufacturing and support preparing quality rated answers for customer requests Enforce strict adherence to internal procedures and GxP requirements supporting right-first-time execution and minimizing delays Support investigations into deviations and non-conformances, ensuring robust root cause analysis, effective CAPA implementation, and timely closure Accelerate by facilitating rapid assessments and ensuring high-quality documentation of quality-related matters Represent QA in daily and weekly shop floor meetings, addressing quality risks and promoting a solutions-oriented mindset Lead and contribute to continuous improvement initiatives that enhance quality performance, reduce waste, and increase operational efficiency Foster a culture of ownership and accountability on the shopfloor , where quality, accountability, and continuous improvement is seen as an enabler
Team / description
Bachem ist ein führendes, innovationsgetriebenes Unternehmen, das sich auf die Entwicklung und Herstellung von Peptiden und Oligonukleotiden spezialisiert hat. Mit einem umfassenden Dienstleistungsangebot bietet Bachem pharmazeutischen und biotechnologischen Unternehmen weltweit Produkte für Forschung, klinische Entwicklung und kommerzielle Anwendung. Mit Hauptsitz in der Schweiz sowie Standorten in Europa, den USA und Asien ist Bachem international tätig und verfügt über mehr als 50 Jahre Erfahrung und eine branchenweit einzigartige Fachkompetenz. Das Unternehmen ist an der SIX Swiss Exchange kotiert.
Qualifications and Skills
University degree (Bachelor/Master) in Chemistry, Organic Chemistry, Natural Sciences, or a comparable scientific or technical discipline, with relevant experience in the field
Minimum of 5 years of professional experience in API manufacturing, preferably within a CDMO environment
Demonstrated expertise in quality assurance, with direct exposure to manufacturing operations
Strong working knowledge of GMP, regulatory requirements, and ALCOA+ principles
High level of interest in manufacturing processes and operational QA topics, with a mindset geared toward best practices and modern technologies
Familiarity with quality systems and documentation processes, including deviation handling, CAPA, and change control
Experience with or willingness to develop skills in Lean, Six Sigma, or other continuous improvement methodologies
Proficient in both written and spoken German and English