Senior QA Expert

À propos de cette offre

Senior QA Expert for QC driving gLIMS implementation and GMP quality oversight within a complex pharmaceutical laboratory environment at Lonza.

Senior QA Expert

Job description:

Work 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.