Be the backbone of innovation and join a leading pharmaceutical company to help keep life-changing science moving forward!

Proclinical is seeking a Senior QA Expert to join a Quality Operations team in Neuchatel, Switzerland. This role focuses on supporting the implementation of a new Fill and Finishing and Visual Inspection area while ensuring compliance with GMP standards and regulatory requirements. You may also be involved in routine GMP operations for the Fill and Finishing area. This is an on-site position with occasional flexibility for remote work based on specific tasks.

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:

• Prepare, evaluate, and approve controlled documentation for creation or revision.
• Review deviations related to production events within quality systems (e.g., Trackwise) to ensure adherence to procedures and regulatory standards.
• Conduct or approve investigations, impact assessments, and define relevant CAPAs.
• Attend meetings relevant to assigned tasks.
• Follow the escalation process as required.
• Complete training and manage software access in line with company policies.
• Support conventional quality oversight tasks, such as continuous improvement initiatives, GMP tours in classified areas, and batch reviews.

Key Skills and Requirements:

• Strong academic background in technical or scientific fields.
• Operational experience in cGMP environments, particularly in Quality Operations for sterile injectable pharmaceutical production.
• Comprehensive understanding of production processes, including cell culture, aseptic filling, equipment, gowning, environmental controls, and laboratory testing.
• Familiarity with cGMP quality guidelines and systems, including deviations, CAPA, change control, training, and documentation.
• Proficient in drafting documents in French and/or English.
• Fluency in both French and English.
• Skilled in using Microsoft Office and other PC-based tools.
• Team-oriented with strong adaptability and autonomy.

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

Apply Now:

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

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