QA Specialist: gLIMS & GMP Compliance Lead

Coopers Group; Stein; On-site; CHF 70,000 - 100,000; Part time

Job summary

Coopers Group is seeking a QA/QC Project Lead in Stein to drive growth initiatives while ensuring GMP compliance across QC activities. The role focuses on implementing the gLIMS system, maintaining SOP accuracy, and guiding QC with a strong emphasis on regulatory adherence.

The candidate will manage GMP documentation, participate in audits, and report KPIs, in a 6-month, 60% workload contract based in Stein.

Qualifications

• 7+ years of experience in projects implementing laboratory execution systems in quality-focused environments.
• Strong background in cGMP regulations (US, European, Japanese Pharmacopoeia).
• Experience interacting with health authorities (FDA, Swissmedic).

Responsibilities

• Collaborate with cross-functional teams on growth projects aligned to site quality objectives and ensure timely delivery under QA/QC responsibility.
• Provide guidance and quality oversight for QC.
• Support growth projects and act as primary QA contact for gLIMS implementation.

Skills

QA/QC oversight

GMP compliance

Cross-functional collaboration

Regulatory knowledge

Tools

gLIMS (Laboratory Execution System)

Job description

Coopers Group is seeking a QA/QC Project Lead in Stein to drive growth initiatives while ensuring GMP compliance across QC activities. The role focuses on implementing the gLIMS system, maintaining SOP accuracy, and guiding QC with a strong emphasis on regulatory adherence.

The candidate will manage GMP documentation, participate in audits, and report KPIs, in a 6-month, 60% workload contract based in Stein.