Hands-on QA Manager – cGMP Pharma (Switzerland)

EPM Scientific; Muttenz; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

EPM Scientific is seeking an experienced Quality Assurance Manager in Switzerland to lead QA oversight across manufacturing, qualification, validation and quality systems within a cGMP-regulated facility.

You will work closely with the Head of QA and Regulatory Affairs, remain hands-on, and drive continuous improvement while ensuring investigations, CAPA and change controls are handled according to applicable standards.

Qualifikationen

• Hands-on QA experience in regulated pharma/manufacturing environments.
• Strong knowledge of cGMP requirements and quality systems.
• Experience with deviations, investigations, CAPA and change controls.
• Knowledge of equipment qualification and process validation.
• German and English professional fluency.

Aufgaben

• Provide QA oversight across manufacturing, qualification, validation, quality systems and continuous improvement activities.
• Review and approve quality documentation including deviations, investigations and change controls.
• Support internal and external audits, supplier quality activities and inspection readiness.
• Collaborate with Production, Quality Control, Engineering and R&D to ensure compliant manufacturing and testing.
• Lead QMS improvements and drive CAPA program to close out within timelines.
• Ensure data integrity and qualification documentation are current and compliant.

Kenntnisse

QA experience

cGMP knowledge

QMS expertise

root cause analysis

CAPA

deviations investigations

change controls

data integrity

audit support

German/English fluency

Ausbildung

Master's or PhD in Chemistry/Engineering/Pharmaceutical Sciences

Tools

CSV (Computer System Validation)

Jobbeschreibung

EPM Scientific is seeking an experienced Quality Assurance Manager in Switzerland to lead QA oversight across manufacturing, qualification, validation and quality systems within a cGMP-regulated facility.

You will work closely with the Head of QA and Regulatory Affairs, remain hands-on, and drive continuous improvement while ensuring investigations, CAPA and change controls are handled according to applicable standards.