QA Asssurance / Engineer

On behalf of our pharmaceutical client in Solothurn, we are seeking a Quality Assurance Engineer for a short-term contract of 4 months.

General Information:

Duration: 4 Months

Location: Solothurn

The QA Engineer will be responsible for quality oversight, including reviewing and approving validation and engineering lifecycle documents such as URS, FS, RTM, RA, DS, configuration specifications, drawings, test protocols, deviations, change controls, work orders, and other technical documentation related to facilities, utilities, equipment, and Biogen Execution System (both global and local computerized systems). The role supports startup, commissioning, and qualification of a new large-scale manufacturing facility. Additionally, the QA Engineer will advise project teams and actively participate in groups requiring quality input.

Key Responsibilities:

• Ensure that equipment, utilities, and facility design, construction, and qualification meet GMP and regulatory standards.
• Review and approve qualification, validation, and engineering documents during project and operational phases.
• Participate in validation and change control processes for BES systems at the Solothurn site.
• Review GMP documentation and data for compliance with applicable procedures and regulatory guidance.
• Manage QA activities related to protocol deviations, test protocols, change controls, and QRMs concerning equipment and automation systems.

Note: If you are not a passport holder of the country where the vacancy is located, you might need a work permit. For more information, please check our blog.

Applicants should not include bank or payment details when applying. All applications must be submitted via the 'Apply now' button. Eurojobs.com is not responsible for external website content.