Associate III – Integrated Downstream Quality Operations

Swisslinx AG; Bezirk Solothurn; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Swisslinx AG is seeking an Associate III – Integrated Downstream Quality Operations to support QA activities across downstream GMP manufacturing. You will collaborate with Manufacturing, Process Engineering, Manufacturing Sciences and Automation teams to ensure compliance and batch release readiness.

The role requires strong QA experience in GMP environments, with emphasis on downstream processing, deviations, investigations and GMP documentation.

Qualifikationen

• 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.

Aufgaben

• Perform batch record review and close-out in preparation for batch release.
• Assist in GMP CAPEX/OPEX projects, shutdowns and new product introductions.
• Participate in Quality On-Call rotation and cross-functional collaboration to ensure GMP compliance.

Kenntnisse

QA oversight

Cross-functional collaboration

Quality systems

Technical writing

Ausbildung

Bachelor’s degree

Master’s degree

Tools

eBR system

LIMS

Kneat

CMMS

Jobbeschreibung

• Until: 31/03/2027 with possible extension
• Department: Quality Assurance / Integrated Downstream Quality Operations

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.

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

Maybe not for you, but for someone else?