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