Quality Projects Specialist, 80-100%

Ophtapharm, a Sentiss Company

Winterthur

Vor Ort

CHF 110.000 - 160.000

Vollzeit

Vor 6 Tagen
Sei unter den ersten Bewerbenden

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Benefits dieser Stelle

Flexible working conditions
Pension scheme
Free parking
Good public transport accessibility

Zusammenfassung

Ophtapharm AG near Winterthur is seeking a Quality Projects Specialist (80-100%) to strengthen our Quality organization. You will oversee QC data systems, support digital transformation, and drive cross-functional quality and compliance projects across the site.

Fluency in German and good English are required. You will provide expert guidance on QC instrumentation, GDP and data integrity, manage risk assessments, and contribute to a culture of continuous improvement with ownership and visibility

Qualifikationen

  • Experience in GMP-regulated environments with QC instrumentation, data integrity, and data lifecycle management.
  • Knowledge of GMP requirements, 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, pragmatic approach.

Aufgaben

  • 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.

Kenntnisse

Analytical mindset
Execution-driven
GMP quality systems
Cross-functional collaboration

Tools

OpenLab
Chromeleon

Jobbeschreibung

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

As part of our Quality organization, you will help shape and strengthen key quality initiatives across the site. Working closely with cross-functional teams, you will oversee QC data systems, support digital transformation initiatives, and contribute to a culture of continuous improvement.

To strengthen our dedicated team, we are looking for an analytical and execution-driven personality to join us at our site in Hettlingen starting as soon as possible or by agreement as Quality Projects Specialist (80-100%).

Your Role
  • 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.
Your Profile
  • 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.
What you can expect
  • The opportunity to shape quality processes in an evolving GMP environment, both internally and with external partners.
  • A role with real ownership, visibility, and influence across functions and leadership levels.
  • The chance to contribute to a significant transformation journey and help build sustainable quality practices for the future.
  • A collaborative culture with short decision-making paths and openness to new ideas.
  • Flexible working conditions, an attractive pension scheme, and convenient accessibility with public transport and free parking.
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