Downstream QA Specialist – GMP & Equipment

Actalent; Bezirk Solothurn; Vor Ort; CHF 90.000 - 120.000; Teilzeit

Zusammenfassung

Actalent, Solothurn, Switzerland, seeks a Quality Assurance Associate to support downstream operations and equipment-focused QA/engineering activities within Integrated Downstream Quality Operations.

The role involves QA execution for GMP manufacturing, document reviews, deviation management collaborations with manufacturing and engineering teams, and participation in batch release processes. On-call and temporary engagement expected with ASAP start.

Qualifikationen

• Bachelor’s or Master’s degree in a relevant field and 4–6 years in pharma/biotech manufacturing.
• Experience with Quality Assurance, Equipment Qualification, and downstream processes preferred.
• English B1 minimum.

Aufgaben

• Executes QA activities related to downstream operations, GMP manufacturing, and downstream equipment.
• Reviews and approves GMP Engineering and Manufacturing documents during project and operations.
• Partners with Manufacturing, Manufacturing Sciences, Process Engineering, and Automation SMEs during deviation management.
• Participates in batch record review and release activities.
• Supports monitoring and release for Column Packing/Unpacking and Chromatography Review.
• Ensures adherence to internal procedures during downstream manufacturing operations or for equipment controls and release.

Kenntnisse

Quality Assurance

Equipment Qualification

Downstream Process

Ausbildung

Bachelor’s or Master’s in relevant field

Jobbeschreibung

Actalent, Solothurn, Switzerland, seeks a Quality Assurance Associate to support downstream operations and equipment-focused QA/engineering activities within Integrated Downstream Quality Operations.

The role involves QA execution for GMP manufacturing, document reviews, deviation management collaborations with manufacturing and engineering teams, and participation in batch release processes. On-call and temporary engagement expected with ASAP start.