Quality Engineering Specialist

Vor 4 Tagen


Basel, Basel-Stadt, Schweiz Cpl Healthcare Vollzeit

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 #J-18808-Ljbffr



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