QA Expert (Senior)

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

Be the driving force behind seamless logistics for a global CMO, where precision and efficiency for quality are key to supporting world-class manufacturing.

Proclinical is seeking a Senior QA Expert for QC to provide quality oversight and support across microbiology projects and departmental initiatives. This role is responsible for ensuring compliance with GMP requirements, reviewing and approving microbiology-related batch documentation, and supporting the implementation of laboratory execution systems. Working closely with cross-functional teams, you will help drive quality excellence while contributing to site objectives and broader strategic priorities.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• 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.
• Undertake additional duties as assigned.

Key Skills and Requirements:

• Strong experience implementing laboratory systems within a quality-driven environment.
• Good working knowledge of clinical regulations, including US, European, and Japanese Pharmacopoeia requirements.
• Proven expertise in the qualification and validation of laboratory equipment and software systems.
• Experience liaising with regulatory authorities, including the FDA and Swissmedic.
• Highly organised with a structured and detail-oriented approach to work.
• Adaptable and proactive, with an open-minded and solution-focused mindset.
• Fluent in English, with German language skills considered an advantage.
• Project management certification, such as Green Belt or Black Belt, would be beneficial.

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