QA Asssurance / Engineer

On behalf of our Pharmaceutical client in Solothurn we are looking for Quality Assurance Engineer for a short term contract of 4 months.

General Information:

Start date: 02.06.2025

Location Solothurn

Responsible for Quality oversight to review and approval of validation and engineering life cycle documents (URS, FS, RTM, RA, DS, configuration spec, drawings etc.), test protocols, deviations, change controls, work orders and any technical documentation in the scope of Facilities, utilities, equipment and Biogen Execution System (global and local computerized systems) to enable start up, commissioning and qualification of new Large Scale Manufacturing facility. Furthermore, advice the project groups as appropriate and be an active member of the groups where quality input is needed.

The holder of this position will be responsible for the following activities:

Ensure Equipment, utilities and facility design, build and qualification is successfully done according to current GMP and regulatory policies.

• Review and approval of Qualification, Validation and Engineering documents during both project and operational phases of the site.
• Involvement in validation and change control of the BES systems being implemented and operated at the Solothurn site.
• Review of GMP documentation and data for compliance to applicable procedures, regulatory and/or corporate guidance documents.

Responsible for QA activities (Protocol deviations, test protocols, change control and QRMs) associated to equipment and automation systems in scope.

If you are interested, please apply with a cop of your CV.

Contact: Elaine Kanwar

Tel: +41 61 282 2223