Senior QA Expert - QC & gLIMS Lead

Proclinical Staffing; Aargau; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Proclinical Staffing seeks a Senior QA Expert for QC to ensure quality oversight across microbiology projects and support GMP-compliant documentation and laboratory systems initiatives.

In this role you will collaborate with cross-functional teams to meet site objectives, review QC batch documentation, drive quality excellence, and uphold health authority guidelines. Right to work in Switzerland or EU passport required; English fluency essential, German a plus.

Qualifikationen

• Experience implementing laboratory systems in a quality-driven environment.
• Knowledge of clinical regulations (US, European, and Japanese Pharmacopoeia).
• Expertise in qualification and validation of laboratory equipment and software systems.
• Experience liaising with regulatory authorities, including the FDA and Swissmedic.
• Highly organized with a structured and detail-oriented approach to work.
• Fluent in English, with German language skills considered an advantage.
• Project management certification (Green Belt or Black Belt) would be beneficial.

Aufgaben

• Collaborate with cross-functional teams to support growth projects aligned with site quality objectives.
• Ensure project timelines and deliverables under QA-QC responsibility are met.
• Provide guidance and quality oversight for Quality Control (QC) activities.
• Act as the primary QA contact for implementing gLIMS laboratory execution systems.
• Represent QA in supporting and guiding the QC department to meet GMP requirements and follow SOPs.
• Review and approve GMP-relevant documents from QC, including SOPs focused on gLIMS implementation.
• Supervise and execute GMP compliance activities such as change requests, document management, and non-conformities.
• Write or revise SOPs within your area of expertise and manage ownership of these documents.
• Support QA in QC raw data review as needed.
• Ensure adherence to internal and external quality and safety guidelines, including regulatory GMP standards and health authority guidance.
• Manage and report KPIs related to quality assurance activities.
• Perform and support inspections and audits as required.

Jobbeschreibung

Proclinical Staffing seeks a Senior QA Expert for QC to ensure quality oversight across microbiology projects and support GMP-compliant documentation and laboratory systems initiatives.

In this role you will collaborate with cross-functional teams to meet site objectives, review QC batch documentation, drive quality excellence, and uphold health authority guidelines. Right to work in Switzerland or EU passport required; English fluency essential, German a plus.