QC Manager Microbiology(m/w/x)

Beschreibung

You will drive operational excellence in the microbiology lab by managing QC processes and ensuring cGMP compliance, while acting as a key technical expert during critical audits and inspections.

Anforderungen

• •University degree in Microbiology or similar
• •Experience in GMP-regulated environment and cross-functional projects
• •Knowledge of international regulatory requirements, cGMP, and pharmaceutical standards
• •In-depth knowledge of laboratory equipment and analytical methods
• •Open communication and effective teamwork
• •High self-awareness, outer awareness, system awareness, and innovation focus
• •High degree of commitment and engagement
• •Strong analytical thinking and decision-making skills
• •Excellent written and spoken German and English

Aufgaben

• •Manage QC processes for release and stability testing
• •Ensure cGMP compliance in the microbiological laboratory
• •Drive continuous development of operational excellence
• •Analyze and evaluate relevant performance KPIs
• •Implement internal and external policies and procedures
• •Train personnel on new specifications and standards
• •Manage the life cycle of microbiological test methods
• •Oversee analytical equipment and raw data documentation
• •Maintain internal product documentation and regulatory dossiers
• •Act as a Subject Matter Expert during audits
• •Manage operational laboratory tasks and HSE topics
• •Support the Head of Quality Control with release decisions

Tools & Technologien

Benefits