Associate III – Integrated Downstream Quality Operations

Job Description
As an Associate III – Integrated Downstream Quality Operations , you will support Quality Assurance activities across downstream GMP manufacturing operations and equipment, working closely with Manufacturing, Process Engineering, Manufacturing Sciences and Automation teams. About The Customer
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Location:
Solothurn, Switzerland
- Workload: 100%
- Start: As soon as possible
- Until: 31/03/2027 with possible extension
- Department: Quality Assurance / Integrated Downstream Quality Operations Requirements
- Provide QA shopfloor oversight for downstream manufacturing operations
- Review electronic batch records (eBR), electronic logbooks, LIMS records and samples
- Review and approve GMP Manufacturing and Engineering documentation
- Manage minor and major deviations and support investigations
- Support CAPAs, change controls and equipment-related quality activities
- Provide Quality oversight for equipment qualification, work orders, P&IDs, qualification protocols and calibration deviations
- Support column packing/unpacking and chromatography review and release
- Perform Quality oversight of PLM, CMMS and Kneat activities
- Participate in batch record review and close-out in preparation for batch release
- Support equipment controls and release during GMP CAPEX/OPEX projects, shutdowns and new product introductions
- Participate in the Quality On-Call rotation
- Collaborate cross-functionally to ensure compliance with applicable GMP and regulatory requirements Competences
- Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations or a related field with at least 6 years of relevant pharmaceutical/biotech manufacturing experience OR Master’s degree in a relevant field with at least 4 years of relevant pharmaceutical/biotech manufacturing experience
- Experience within a GMP pharmaceutical or biotechnology manufacturing environment
- Experience in Quality Assurance; exposure to downstream processing and equipment qualification is strongly preferred
- Experience with deviations, investigations and GMP documentation
- Understanding of downstream manufacturing operations and equipment
- Ability to work autonomously and effectively with cross-functional teams
- Strong organizational, writing, presentation and problem-solving skills