Join a dynamic team at a leading Contract Manufacturing Organisation (CMO) and contribute to groundbreaking projects and cutting-edge solutions.

Proclinical is seeking a dedicated QA Associate to join our client's team in Solothurn, Switzerland. In this role, you will provide quality oversight for the review and approval of various validation and engineering lifecycle documents. Your focus will be on ensuring compliance with GMP and regulatory policies during the startup, commissioning, and qualification of a new large-scale manufacturing facility. This position requires collaboration across multiple functions and levels within the organization.

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:

• Oversee the design, build, and qualification of equipment, utilities, and facilities in line with GMP and regulatory standards.
• Review and approve qualification, validation, and engineering documents during project and operational phases.
• Participate in the validation and change control processes for Biogen Execution Systems (BES) at the site.
• Ensure GMP documentation and data comply with applicable procedures and regulatory guidelines.
• Manage QA activities related to protocol deviations, test protocols, change control, and QRMs for equipment and automation systems.

Key Skills and Requirements:

• Strong communication skills in English, both verbal and written.
• Technical expertise in the validation of laboratory and production equipment, with knowledge of biopharmaceutical drug substance production.
• Self-motivated with the ability to take ownership of assignments and work collaboratively in a team environment.
• Capable of making informed technical decisions and prioritizing tasks effectively.
• Flexible and able to manage multiple activities simultaneously.

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

Apply Now:

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy