Quality Assurance Associate III
Randstad (Switzerland) Ltd.
Date de publication :
08 mars 2025Taux d'activité :
100%- Lieu de travail :Luterbach
job details
For one of our clients, a leading international biotechnology company, we are looking for Quality Assurance Associate III - Integrated Downstream Quality Operations.
General Information:
About the job:
The Associate III within the Integrated Downstream Quality Operations team is 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.
Tasks & Responsibilities:
Requirements:
Apply Now!
If this sounds like the right opportunity for you, we look forward to receiving your application!
General Information:
- Start date: 01.04.2025
- End date: 31.10.2025
- Workplace: Luterbach, Solothurn
- Workload: 100%
- Working hours: Standard
About the job:
The Associate III within the Integrated Downstream Quality Operations team is 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.
Tasks & 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.
- Takes 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
- Takes part of the Quality On-Call duty rotation for Quality
- Participates in batch record review and close out in the view of batch release.
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.
- Demonstrated ability to work autonomously with cross-functional team members.
- Strong presentation and organizational skills
- Demonstrated writing skills
- Demonstrated problem solving skills
- English - minimum B1 level
Apply Now!
If this sounds like the right opportunity for you, we look forward to receiving your application!
