About us
Coriolis Pharma is a global contract research and development organization (CRDO) and a premier partner for the development of liquid and lyophilized drug products, analytical services, and manufacturing services across a vast array of therapeutic modalities, including biologics, gene and cell therapies and vaccines.
Our scientists design and execute platform and custom services to accelerate and derisk our clients’ programs right from the start and throughout the entire product lifecycle. Our company culture is based on diversity, teamwork and open and appreciative communication. That's why wonderful people from over 36 nations around the world work together successfully at Coriolis. Our headquarters are located in Martinsried near Munich, Germany. An additional project management and business development team in the United States enables our US clients to work seamlessly with our German offices.
What motivates us? Our motivation is to improve the quality of life for humankind by enabling the development of innovative drugs through outstanding biopharmaceutical services from preclinical to commercialization
Qualification Specialist (f/m/d)
Permanent employee, Full-time · Martinsried (BY)
Purpose of your Job
The position holder is responsible for ensuring the operational support of the Quality Control (QC) unit by managing and maintaining QC laboratory equipment in compliance with Good Manufacturing Practice (GMP) standards. This role involves overseeing system ownership of QC instruments, coordinating equipment maintenance and qualification, and supporting laboratory readiness for audits and inspections. Additionally, the role includes executing routine QC tasks, reviewing documentation, and conducting instrument training to uphold the integrity and efficiency of laboratory operations.
Execution of compilation and review of SOP, QC templates and reports
Support in the cause of preparation of QC laboratories for audits and inspections
Execution of instrument trainings including documentation of trainings
Review of instrument logbooks and performance-documents of equipment
Compilation of (re)qualification documents for GMP systems
Organization and performance of (re)qualification work
System ownership of different GMP equipment e.g., standard laboratory equipment and complex instruments
Material receipt and sample receipt including organization of documentation
Execution of routine QC tasks to ensure the proper working status of the laboratory e.g., calibration, cleaning and maintenance tasks
Bachelor or equivalent, university degree in (bio) chemistry, biology, medical sciences, pharmacy or related field, MTA, BTA or CTA or equivalent formal education
Experienced in the area of QC equipment qualification according to GMP guidelines
3-5 years of relevant experience in a pharmaceutical company as technical GMP expert
Strong written and verbal knowledge of English
Strong communication and organizational skills
In-depth knowledge of instrument qualification processes
Electronic data processing skills
Let’s formulate innovation together…
Our success & development is created by the people working together @Coriolis. We put People first! That’s why we have a growth mindset, and value personality, collaboration and community to create an empowering and inspiring working space with focus on quality and customers.
We would like to grow together with you!
Let’s continue building and creating the future now! Join our Team of currently around 200 employees. In a highly motivated and interdisciplinary team, we provide you with a great chance to increase your experience. We offer an attractive work space at the Martinsried site. Let’s make a difference together!
Coriolis Pharma is an equal opportunity employer and welcomes applications from all qualified individuals regardless of ethnicity, citizenship or gender identity, color, disability, religion/belief, personal orientation, marital status, age or individual preferences. Different backgrounds, experiences and ideas push us further and raise the bar.