Beschreibung

In this role, you will lead device and incoming goods testing activities, ensuring compliance with quality standards while fostering a safe and efficient laboratory environment. Your daily responsibilities will include supervising staff, conducting tests, and collaborating with various teams to support product quality.

Anforderungen

• •Master's degree or Bachelor's with extensive practical experience in GMP, management science related field
• •Sufficient qualification for Head of Quality Control
• •Minimum of 5-10 years of regulated industry experience in QC
• •Experience with Devices and Incoming goods testing
• •Previous experience with Laboratory IT systems such as LIMS and LES
• •People management
• •Fluent written and oral skills in German and English
• •Participation in Regulatory inspections such as EMA, FDA
• •Management experience of third-party laboratories
• •Demonstrated knowledge and application of regulations applicable to the pharmaceutical industry and related quality systems
• •Ability to mentor / train others, share learning
• •Ability to travel (approximately 10-20 %)

Aufgaben

• •Manage device testing and incoming goods testing activities
• •Maintain a safe work environment and lead safety initiatives
• •Ensure compliance with cGMP procedures and Quality Systems
• •Supervise laboratory personnel and set performance standards
• •Perform laboratory device testing for commercial products
• •Manage incoming goods testing for commercial products
• •Conduct method transfer, verification, and validation
• •Participate in flow and process teams for collaboration
• •Handle change management and deviation management
• •Conduct laboratory investigations
• •Organize the lab according to the 5S principle
• •Ensure proper training for all analysts and technicians
• •Build and maintain relationships with testing labs across the network
• •Oversee QC laboratory equipment setup and qualification
• •Support regulatory submissions and inspections

Tools & Technologien

Benefits