QA Asssurance / Engineer

Experis Schweiz; Solothurn; Vor Ort; CHF 80’000 - 100’000; Vollzeit

Zusammenfassung

A leading company within the pharmaceutical sector seeks a Quality Assurance Engineer for a 4-month contract based in Solothurn. The role involves overseeing quality checks, validating engineering documents, and ensuring compliance with regulatory standards. The successful candidate will actively participate in the project groups to provide quality input, ensuring all processes meet GMP compliance.

Qualifikationen

• Experience in quality oversight and validation in the pharmaceutical sector.
• Strong knowledge of GMP and regulatory policies.
• Capability to review technical documentation and assist project groups.

Aufgaben

• Review and approve qualification and validation documents.
• Ensure compliance with GMP standards during project and operational phases.
• Responsible for QA activities related to equipment and automation systems.

Kenntnisse

Quality Assurance

GMP Compliance

Validation

Documentation review

Jobbeschreibung

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

Duration: 4 Months

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: [phone]