Description
We are looking for a
QA Specialist Logistics & Transport (m/f)
Reference: -en
Start: asap
Duration: 18 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Working in close collaboration with the Logistics & Transport department providing QA advice with regard to cGMP/cGDP-compliance, with reference to the company’s national and international standards
- Oversight of the discrepancy management system at Logistics & Transport while managing, monitoring and trending discrepancies and non-conformities
- Manage, monitor and trend corrective and preventive actions in TrackWise
- As change controller support the change management process within the area of responsibility
- Release function for new and existing data loggers
- Support audit readiness
- Supervise the cleaning and pest control program of the logistic hubs
- As QA SME assist the team with the management and qualification activities of shipping systems
- Continuously monitor the quality management system to guarantee continuous improvement within the area of responsibility
- Develop or maintain GMP documentation for the team
Your qualifications
- University degree in natural science is desired
- Experience in the pharmaceutical industry, preferred in quality assurance
- Very good knowledge and working experience in EU and international regulations (e.g. WHO, EU-GDPs, GMPs)
- GMP/GDP knowledge is required
- Experience with validation/qualification activities is of advantage
- Ability to communicate in German and English, both orally and in writing is mandatory
- TrackWise knowledge is a plus
Skills:
- Quality manager