QA Associate III

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

For our client based in Solothurn (Switzerland), we are looking for a Quality Assurance Associate to work in the Integrated Downstream Quality Operations team. The person will focus on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment.

Responsibilities

• Executes QA activities related to downstream operations, GMP manufacturing, and downstream equipment to ensure the safety, efficacy and purity of the products manufactured
• 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
• Participates in batch record review and close out in the view of batch release

Must-haves

• Bachelor’s degree or Master’s degree in relevant field such as Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations and at least 4 to 6 years of experience in pharmaceutical or biotech manufacturing environment.
• Experience with Quality Assurance, Equipment Qualification, Downstream Process is preferred.
• English B1 as a minimum.

Contract Type: Temporary - From 01/11/2026 until 31/03/2027

Start Date: ASAP

On-call: Take part of the On-Call duty rotation for Quality

While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.