For our client, a leading biotechnology company based in Solothurn, we are seeking a (Senior) Quality Assurance Associate to join the Integrated Downstream Quality Operations team.
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job details
summary
- luterbach, solothurn
- temporary
- job categoryscience & research
job details
In this role, you will be a part of the Quality Department at the new Large-Scale Manufacturing facility. You will focus 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.
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General Information:
- Start date: 01.11.2026
- End date: 31.03.2027
- Extension: to be discussed
- Contract type: temporary contract via Randstad (employment)
- Workplace: Luterbach, Solothurn
- Workload: 100%
Tasks & Responsibilities:
- Executes QA activities related to downstream operations, GMP manufacturing and downstream equipment to ensure the safety, efficacy and purity of the products.
- 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.
Your Profile:
- Bachelor’s degree in relevant field with at least 6 years of experience in pharmaceutical or biotech manufacturing environment.
- or Master’s degree in relevant field with at least 4 years of experience in pharmaceutical or biotech manufacturing environment.
- Experience with Quality Assurance, Equipment Qualification, Downstream Process.
- Demonstrated ability to work autonomously with cross-functional team members.
- Strong presentation and organizational skills.
- Demonstrated writing skills.
- Demonstrated problem solving skills.
- Excellent written and spoken communication in English (minimum B1 level)
Sounds interesting? Apply now – we’re looking forward to receiving your applications!
For our client, a leading biotechnology company based in Solothurn, we are seeking a (Senior) Quality Assurance Associate to join the Integrated Downstream Quality Operations team.
In this role, you will be a part of the Quality Department at the new Large-Scale Manufacturing facility. You will focus 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: to be discussed
- Contract type: temporary contract via Randstad (employment)
- Workplace: Luterbach, Solothurn
- Workload: 100%
Tasks & Responsibilities: ...
- Executes QA activities related to downstream operations, GMP manufacturing and downstream equipment to ensure the safety, efficacy and purity of the products.
- 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.
Your Profile:
- Bachelor’s degree in relevant field with at least 6 years of experience in pharmaceutical or biotech manufacturing environment.
- or Master’s degree in relevant field with at least 4 years of experience in pharmaceutical or biotech manufacturing environment.
- Experience with Quality Assurance, Equipment Qualification, Downstream Process.
- Demonstrated ability to work autonomously with cross-functional team members.
- Strong presentation and organizational skills.
- Demonstrated writing skills.
- Demonstrated problem solving skills.
- Excellent written and spoken communication in English (minimum B1 level)
Sounds interesting? Apply now – we’re looking forward to receiving your applications!
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