QA Expert

Be the quality guardian who secures compliance and precision in aseptic manufacturing.

Proclinical is seeking a QA Expert to join a dynamic team in Switzerland. This role focuses on providing quality assurance expertise within the implementation of a new Fill and Finishing process. You will also support routine GMP operations in this area, ensuring compliance with current guidelines and regulatory requirements. This is an on-site position with occasional remote work possible for specific tasks.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Approve aseptic interventions performed during Aseptic Process Simulations on the manufacturing floor.
• Review Master Batch Records to ensure accuracy and compliance.
• Attend relevant meetings to support assigned tasks.
• Adhere to the escalation process for quality-related issues.
• Complete required training and manage software access in line with company policies.
• Support additional quality oversight tasks, such as continuous improvement initiatives, GMP tours in classified areas, and more.

Key Skills and Requirements:

• Strong academic background in technical or scientific fields.
• Hands-on experience in cGMP operations within a pharmaceutical production environment, particularly sterile injectable products.
• Comprehensive understanding of production processes, including cell culture, aseptic filling, gowning, environmental controls, and laboratory testing.
• Familiarity with quality systems such as Deviations, CAPA, Change Control, Training, and Documentation.
• Proficient in drafting documents in French and/or English.
• Fluency in both French and English.
• Proficient in Microsoft Office and other PC-based tools.
• Team-oriented with strong adaptability and autonomy.
• On-site presence required at least four days per week, with flexibility during aseptic simulation tests.

For more information, please contact Molly Colclough.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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