Proclinical is seeking a Quality Engineering Specialist to join our client's team in Visp, Switzerland. This role focuses on ensuring the quality of technical facilities, equipment, and systems within the cardiovascular sector. We are looking for someone who can support and lead qualification activities, document reviews, and quality risk analysis. This position requires a proactive individual with strong communication skills, capable of working collaboratively in a multidisciplinary team.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Manage quality related responsibilities for daily qualification activities on technical facilities, equipment, and systems.
- Support the development, review, and release of qualification documents.
- Approve applicable qualification documents.
- Assess and approve change requests related to the qualified state condition.
- Ensure deviations are investigated and addressed in deviation reports.
- Inform the Group Manager QA Qualification about relevant developments and trends.
- Support the formulation and development of qualification strategies and training.
- Participate in internal audits, customer audits, and official inspections as a QA representative.
Key Skills and Requirements:
- Experience in a biotechnology or pharmaceutical environment.
- Experience in QA Qualification.
- Knowledge of FAT/SAT/IQ/OQ/PQ processes.
- Proactive with strong communication skills.
- Ability to work in a multidisciplinary team.
- Fluent in English (spoken and written).
- Up to 2 days of remote work possible.