QA Asssurance / Engineer

Experis; Solothurn; Vor Ort; CHF 75’000 - 115’000; Vollzeit

Zusammenfassung

A reputable pharmaceutical company in Solothurn is looking for a Quality Assurance Engineer for a 4-month contract. The role involves ensuring compliance with GMP standards, reviewing validation documents, and participating in project teams. Ideal candidates will have a background in quality assurance within the pharmaceutical sector and be familiar with regulatory requirements.

Qualifikationen

• Experience in quality assurance within the pharmaceutical industry.
• Strong understanding of GMP and regulatory standards.
• Familiarity with validation processes and lifecycle documents.

Aufgaben

• Ensure compliance with GMP and regulatory standards.
• Review and approve engineering and validation documents.
• Manage QA activities related to protocol deviations and test protocols.

Kenntnisse

Quality oversight

GMP compliance

Validation and engineering documents review

Jobbeschreibung

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.

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