Senior Investigator, Sterile Microbiology & Manufacturing

Ophtapharm AG; Hettlingen; Sur place; CHF 120 000 - 160 000; Plein temps

Avantages offerts par ce poste

Pension plan

Free parking

Public transport access

Résumé du poste

Ophtapharm AG in Hettlingen near Winterthur seeks a Senior Quality Investigator for Sterile Manufacturing & Microbiology (80-100%). You will lead investigations related to sterility and contamination, define strategies with SMEs, and drive CAPAs based on microbiological data.

Collaboration with QA, Manufacturing and Regulatory Affairs is key. The role emphasizes regulatory compliance, audits, and coaching investigators, with a focus on aseptic processing and environmental monitoring in a GMP

Qualifications

• Degree in Microbiology, Biology, Pharmacy or related life-science.
• 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.

Responsabilités

• 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.

Connaissances

GMP experience

Environmental monitoring

Root cause analysis

CAPA implementation

English fluency

German knowledge

Veeva experience

Formation

Degree in Microbiology, Biology, Pharmacy or related life-science

Outils

Veeva

Description du poste

Ophtapharm AG in Hettlingen near Winterthur seeks a Senior Quality Investigator for Sterile Manufacturing & Microbiology (80-100%). You will lead investigations related to sterility and contamination, define strategies with SMEs, and drive CAPAs based on microbiological data.

Collaboration with QA, Manufacturing and Regulatory Affairs is key. The role emphasizes regulatory compliance, audits, and coaching investigators, with a focus on aseptic processing and environmental monitoring in a GMP