Beschreibung

In this role, you will lead the microbiology laboratory, ensuring compliance with safety and quality standards while managing testing activities. Your daily responsibilities will include supervising staff, conducting tests, and collaborating with various teams to maintain efficient operations.

Anforderungen

• •Masters degree or Bachelor’s degree with extensive relevant work experience in microbiology
• •Minimum of 5-10 years of regulated industry experience in QC
• •Experience with microbiology testing
• •Previous experience with Laboratory IT systems such as MODA, LIMS and LES
• •Leadership experience
• •Written and oral skills in German and English
• •Participation in Regulatory inspections such as EMA, FDA
• •Demonstrated knowledge and application of regulations in the pharmaceutical industry
• •Management experience of third-party laboratories
• •Ability to mentor and train others
• •Ability to travel approximately 10-20%

Aufgaben

• •Manage microbiology testing for Parental Manufacturing
• •Maintain a safe work environment and lead safety initiatives
• •Ensure compliance with cGMP procedures and Quality Systems
• •Lead and direct laboratory personnel
• •Supervise microbiology lab activities
• •Perform microbiological testing for commercial products
• •Manage analysis of environmental monitoring samples
• •Oversee external testing activities
• •Verify methods according to pharmacopoeia guidelines
• •Participate in flow and process teams for collaboration
• •Manage change and deviations in the laboratory
• •Conduct laboratory investigations
• •Organize the lab following lean principles
• •Ensure proper training for all Analysts and Technicians
• •Build relationships with microbiology testing labs in the network
• •Oversee QC laboratory equipment setup and operation
• •Support regulatory submissions and inspections

Tools & Technologien

Benefits