Downstream Quality Operations Specialist — GMP & QA

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

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.