Overview
Quality Assurance Associate Jobs in Solothurn, Solothurn, Switzerland at Real Staffing
Title: Quality Assurance Associate
Company: Real Staffing
Location: Solothurn, Solothurn, Switzerland
QA Associate
Location: Solothurn, CH
Duration: 01/04/2025 to 31/10/2025
This role 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.
Key Reponsibilites:
Executes QA activities related to downstream operations, GMP manufacturing, and downstream equipment to ensure the safety, efficacy and purity of the products manufactured by the company
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.
Key requirements:
Bachelor’s degree in relevant field such as Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations and at least 5 years of experience in pharmaceutical or biotech manufacturing environment.
Master’s degree in relevant field such as Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations and at least 3 successful years of experience in pharmaceutical or biotech manufacturing environment.
Experience with Quality Assurance, Equipment Qualification, Downstream Process is preferred.
Ability to monitor and control batch production, ensuring consistency and quality.
Proficiency in maintaining accurate and detailed records of production processes, deviations, and corrective actions.
In-depth understanding of GMP regulations and guidelines.
Demonstrated ability to work autonomously with cross-functional team members.
Strong presentation and organizational skills
Demonstrated writing skills
Demonstrated problem solving skills
Holds an EU passport or valid Swiss work permit
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
