Quality Engineering Specialist – CH (Contract Role)
π Contract Duration: 03/02/2025 – 01/08/2025
π Location: Switzerland (Hybrid – max. 2 days home office)
π Languages Required: Fluent English (German is a plus)
About the Role
We are looking for an experienced Quality Engineering Specialist to support qualification activities in a biotechnology or pharmaceutical environment. This role involves ensuring compliance with GMP standards, reviewing and approving qualification documents, and assessing quality risks related to technical facilities, equipment, and systems.
Key Responsibilities
β Daily oversight of qualification activities for technical facilities, equipment, and systems.
β Review and approval of qualification documents (FAT/SAT/IQ/OQ/PQ).
β Change control assessment to maintain a validated state and ensure compliance.
β Deviation investigation and risk assessment (e.g., GMP-FMEA).
β Support internal & external audits as a QA representative.
β Develop and enhance qualification strategies and provide training as needed.
β Monitor regulatory trends and ensure compliance with industry expectations.
Key Requirements
β Experience in a GMP-regulated biotechnology or pharmaceutical environment.
β QA qualification experience with a strong understanding of FAT/SAT/IQ/OQ/PQ.
β Proactive mindset, strong communication skills, and ability to work cross-functionally.
β Fluent English (spoken & written).
β Hybrid work model (max. 2 days home office).
Beneficial Skills (Nice to Have)
β Experience in risk analysis.
β German language skills.
β Familiarity with SAP, DMS, and TrackWise.
β Strong independent and proactive work approach.
π© Interested? Apply now and contribute to quality excellence in a dynamic environment!
