Senior Quality Investigator: Sterile Microbiology

Job-Room; Hettlingen; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

Pension plan

Free parking

Public transport access

Zusammenfassung

Ophtapharm AG in Hettlingen is seeking a Senior Quality Investigator to lead major sterility, contamination and environmental monitoring investigations in a GMP sterile manufacturing environment. You will define strategies, sampling plans and CAPAs, working with QA, Manufacturing and Regulatory Affairs to ensure product quality and regulatory compliance.

The role offers ownership of critical investigations and opportunity to shape contamination control practices, with collaboration across QA,

Qualifikationen

• Degree in Microbiology, Biology, Pharmacy or related life-science discipline.
• Extensive GMP experience in aseptic manufacturing, sterile operations or microbiology.
• Proven track record leading complex contamination, sterility or environmental monitoring investigations.
• Strong knowledge of EU GMP Annex 1, contamination control and aseptic processing.
• Fluent English; German and Veeva experience are advantageous.

Aufgaben

• Lead major and critical investigations related to sterility, contamination, environmental monitoring and aseptic operations.
• Define investigation strategies, containment measures and sampling plans together with SMEs and the FvP.
• Identify root causes and drive effective CAPAs based on microbiological, process and manufacturing data.
• Review and approve investigations, ensuring scientific rigor and regulatory compliance.
• Support audits and inspections and coach investigators on complex cases.

Kenntnisse

GMP experience

Root-cause analysis

Leadership

English fluent

Aseptic processing

Ausbildung

Degree in Microbiology/Life Science

Tools

Veeva

Jobbeschreibung

Ophtapharm AG in Hettlingen is seeking a Senior Quality Investigator to lead major sterility, contamination and environmental monitoring investigations in a GMP sterile manufacturing environment. You will define strategies, sampling plans and CAPAs, working with QA, Manufacturing and Regulatory Affairs to ensure product quality and regulatory compliance.

The role offers ownership of critical investigations and opportunity to shape contamination control practices, with collaboration across QA,