QC Specialist II
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
The Technology and User Services (TUS) group in NX is driven to help users use tools effectively to improve productivity and foster innovation. We deliver the Technology and User Services (TUS) group in NX to help customers use tools effectively to improve productivity and foster innovation. Our organization is here providing the technology backbone and devices that enable users to work in an office, lab or mobile environment.
QC Specialist II
This position ensures the functionality of laboratory equipment through its (re-) qualification. This includes change management, deviation handling, and the execution of compliance tasks.
This position is limited for 3 years.
Major accountabilities:
- Deviation handling, definition of CAPAs and Action
- Change management handling
- cGxP compliant review and approval of (re-) qualification activities of analytical devices (e.g. HPLCs, pH-Meter, pipettes, water baths) and release of those devices
- Performance of qualification of analytical devices
- Execution of compliance tasks (e.g. annual user review, periodic validation review, alarm reports)
- SME in customer and health authority inspections, and DQC implementation (e.g. Empower, LabX)
Essential Requirements:
- 3-5years experience in Pharma/Manufacturing sector in analytical lab or university degree in biology, chemistry, pharmacy or any other related field
- Working experience in the field of GMP production/Quality Assurance or Quality Control
- Good knowledge of MS office applications and other standard IT applications and security
- Risk Management, managing resources
- Quality Control Sampling and Quality Control (QC) Testing
- Laboratory Excellence and Innovative & analytical technologies
- Knowledge of TQM and related industry GxP standards and processes
- Fluent English and German required
