Quality Projects Specialist

Manage QC instrumentation data and lifecycle activities to ensure GMP compliance. Drive cross-functional quality and compliance projects with measurable business and quality impact. Conduct risk assessments and drive compliance improvement initiatives. Provide expert guidance on QC instrumentation, computerized systems, and GDP requirements.

Ophtapharm AG is an FDA/EU-GMP certified manufacturer in the pharmaceutical sector (ophthalmic products). At our production site in Hettlingen near Winterthur, high-quality products such as eye drops, ointments, and gels are aseptically produced, filled, and packaged for international markets.

• Experience in GMP-regulated environments, including QC instrumentation, Data Integrity, and data lifecycle management.

• Knowledge of GMP requirements, Good Documentation Practices (GDP), computerized systems, and Data Integrity principles.

• Experience in cross-functional projects and laboratory systems such as OpenLab and Chromeleon.

• Strong analytical and problem-solving skills with a structured and pragmatic approach.

• Fluency in German and good working knowledge of English.