Associate III - Integrated Downstream Quality Operations

Swisslinx Solothurn, Switzerland

Posted 8 hours ago Contract Competitive

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:

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

Job ID 35157737

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