Senior QA Expert

Swisslinx; Stein; Vor Ort; CHF 110.000 - 140.000; Teilzeit

Zusammenfassung

Swisslinx seeks an experienced QA professional to lead QC QA oversight during the implementation of a laboratory execution system (gLIMS) in a Life Sciences setting. You will ensure GMP compliance, review QC documentation, and drive SOP development while coordinating with cross-functional teams.

The role focuses on supporting the QC department, managing deviations, and facilitating QA inspections. Fluent English is required; German is a plus.

Qualifikationen

• Provide QA oversight and guidance to QC department ensuring GMP compliance and internal procedures.
• Act as the primary QA contact for the implementation of gLIMS/LIMS.
• Support cross-functional growth projects and ensure QA deliverables meet timelines.
• Review and approve GMP-relevant QC documentation including SOPs for gLIMS.

Aufgaben

• Provide QA oversight and guidance to the QC department, ensuring GMP compliance.
• Act as the primary QA point of contact for gLIMS/LIMS implementation.
• Support cross-functional projects and ensure QA/QC deliverables meet timelines.
• Review and approve GMP-related QC documentation and SOPs for gLIMS.
• Manage quality activities including change requests, deviations and document management.
• Write, revise and own SOPs within your area of expertise.
• Support QC raw data review where required.
• Ensure compliance with internal quality standards and health authority guidance.
• Support inspections and audits and contribute to KPI reporting.

Kenntnisse

LIMS implementation

GMP compliance

Quality Assurance

SOP development

CSV/Validation

Regulatory liaison

Project management

Cross-functional collaboration

Tools

gLIMS/LIMS software

Jobbeschreibung

Job DescriptionWork with a leading Life Sciences organisation on a key Quality Assurance project supporting QC Microbiology and the implementation of a new laboratory execution system.

About The Customer

• Location: Stein, Aargau
• Start: ASAP / September 2026
• Duration: Until 28 February 2027
• Workload: 60%
• Language: Fluent English required; German is an advantage

Requirements

• Provide QA oversight and guidance to the Quality Control department, ensuring compliance with GMP requirements and internal procedures.
• Act as the primary QA point of contact for the implementation of gLIMS / Laboratory Information Management Systems (LIMS).
• Support cross-functional growth projects and ensure QA/QC deliverables are completed according to agreed timelines.
• Review and approve GMP-relevant QC documentation, including SOPs related to the gLIMS implementation.
• Manage quality activities including change requests, deviations/non-conformities and document management.
• Write, revise and own SOPs within your area of expertise.
• Support QC raw data review where required.
• Ensure compliance with internal quality standards, regulatory GMP requirements and health authority guidance.
• Support inspections and audits and contribute to KPI management and reporting.

Competences

• 8+ years of experience supporting projects involving the implementation of laboratory execution systems within a quality-focused environment.
• Strong hands-on experience with gLIMS / LIMS implementation.
• Strong background in cGMP regulations and pharmaceutical Quality Assurance / Quality Control.
• Very good understanding of laboratory environments, equipment, software qualification and validation.
• Experience with Computer System Validation (CSV) is highly advantageous.
• Experience interacting with health authorities such as FDA and Swissmedic.
• Knowledge of US, European and Japanese Pharmacopoeia requirements.
• Structured, organised and solution-oriented approach with the ability to work effectively across functions.
• Fluent English; German is a plus.
• Project management or continuous improvement certification such as Green Belt / Black Belt is an advantage.