Quality Assurance Associate III

Manpower; Bezirk Solothurn; Vor Ort; CHF 90.000 - 140.000; Vollzeit

Zusammenfassung

Manpower in Solothurn is seeking an Associate III to join the Integrated Downstream Quality Operations team at the new Large-Scale Manufacturing facility. The role focuses on Quality Operations and Quality Engineering for downstream manufacturing and equipment, with a fully integrated electronic batch record planned for commercial, clinical and PPQ campaigns.

Start Date: 01.11.2026 • End Date: 31.03.2027 (extension planned) • Location: Solothurn • Department: Quality Assurance, Integrated

Qualifikationen

• Experience with Quality Assurance, Equipment Qualification, and Downstream Process is preferred.
• Strong presentation and organizational skills are required.
• Demonstrated writing skills are essential.
• Demonstrated problem solving skills are needed.
• English: minimum B1.

Aufgaben

• Executes QA activities related to downstream operations, GMP manufacturing, and downstream equipment to ensure safety, efficacy and purity of products.
• Reviews and approves GMP Engineering and Manufacturing documents during project and operational phases, including procedures, work instructions, CAPAs, deviations, change control, equipment, etc.

Kenntnisse

Quality Assurance

Equipment Qualification

Downstream Process

Cross-functional collaboration

Problem solving

Written communication

Presentation skills

Autonomous work

English (B1)

Jobbeschreibung

Manpower

The role:

The Associate III within the Integrated Downstream Quality Operations team is being part of the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/She focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment. The Solothurn site is intended to operate with a fully integrated electronic batch record for all commercial, clinical and PPQ campaigns.

General Information:

Start Date: 01.11.2026

End Date: 31.03.2027 (extension planned)

Location: Solothurn

Department: Quality Assurance, Integrated Downstream Quality Operations

Responsibilities:

• Executes QA activities related to downstream operations, GMP manufacturing, and downstream equipment to ensure the safety, efficacy and purity of the products manufactured by Biogen
• Reviews and approves GMP Engineering and Manufacturing documents during both project and operational phases of the site, specifically related to procedures, work instructions, CAPAs, deviations, change control, equipment (work orders, P&IDs, qualification protocols, calibration deviations..,) etc.
• Partners with Manufacturing, Manufacturing Sciences, Process Engineering, Automation SMEs during deviation management and investigations.
• Take part to the monitoring and release activities for Column Packing / Unpacking and Chromatography Review.
• Ensures adherence to internal procedures during downstream manufacturing operations or for equipment controls and release before and during GMP CAPEX and OPEX project (i.e., shutdowns, construction projects) or New product introduction
• Take part of the Quality On-Call duty rotation for Quality - Participates in batch record review and close out in the view of batch release.
• Experience with Quality Assurance, Equipment Qualification, Downstream Process is preferred.
• Demonstrated ability to work autonomously with cross-functional team members.
• Strong presentation and organizational skills
• Demonstrated writing skills
• Demonstrated problem solving skills
• English B1 as a minimum.

Branche: Pharmaindustrie Funktion: Personalwesen