Qualification Specialist

**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.

**Your Responsibility**:

- 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

**What you need to succeed**:

- 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

**Why to join Coriolis?**:
**_ Let’s formulate innovation together _**:
**_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_

**_Please use our career portal exclusively for this purpose._**:

- We would like to support you from the very beginning to shape your development possibilities here at Coriolis._
- For questions or further information, please visit our website or contact us directly._

**Your Contact**:
**_ Dominik Schwemmer_**:

- Senior Business Partner - Talent & Development_
- People, Organization & Culture Unit_
- Coriolis Pharma Research GmbH_
- Phone: +49 (0) 89 - 417760 - 0_
- Fraunhoferstraße 18 b, 82152 Martinsried_

**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