GMP QA Lead – Microbiology & gLIMS Expert

Panda International; Stein; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Panda International in Stein, Switzerland, seeks a QA professional to oversee QC microbiology, ensuring GMP compliance and timely delivery of project goals. You will review and release batch-related microbiology documents and support cross-functional teams.

The role requires 8+ years in lab execution systems projects, strong cGMP knowledge, experience with health authorities, and fluency in English (German desirable). You will manage KPIs, audits, and SOP ownership.

Qualifikationen

• 8 years+ experience in projects implementing laboratory execution systems in a quality-focused environment.
• Strong background in cGMP regulations (US, European, Japanese Pharmacopoeia).
• Experience interacting with health authorities (FDA, Swissmedic, etc.).
• Fluent in English; German language skills are a plus.

Aufgaben

• Collaborate with cross-functional teams to meet site quality objectives and timelines.
• Provide guidance and quality oversight for QC activities.
• Lead the implementation of gLIMS (laboratory execution system).
• Review and approve GMP-relevant documents and SOPs; manage changes and document control.
• Supervise GMP compliance activities like changes (CRs) and non-conformities (DRs).
• Write or revise SOPs and own these documents.
• Manage KPIs and conduct inspections and audits as required.

Kenntnisse

GMP compliance

Quality assurance

Project management

Regulatory knowledge

Audit & inspection

English fluency

German language

Tools

Laboratory execution systems (LIMS)

Jobbeschreibung

Panda International in Stein, Switzerland, seeks a QA professional to oversee QC microbiology, ensuring GMP compliance and timely delivery of project goals. You will review and release batch-related microbiology documents and support cross-functional teams.

The role requires 8+ years in lab execution systems projects, strong cGMP knowledge, experience with health authorities, and fluency in English (German desirable). You will manage KPIs, audits, and SOP ownership.