QA Computer System and Validation Expert
Merck KGaA Darmstadt, Germany
Corsier-sur-Vevey, Switzerland
vor 5 Tg.

A career at our company is an ongoing journey of discovery : our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials.

For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Your Role

Within the scope of a challenging, ambitious and future-oriented project driven by a dynamic team in an inspiring environment you will elaborate the computerized systems quality strategy including all aspects of data integrity.

You will participate in risk assessments, collaborate with the Computerized systems and equipment validation project teams ensuring that all the deliverables meet quality specifications, and review and approval of GxP documents (including URS, traceability matrix, risk assessments, systems drawing, procedures, qualification and validation documents).

You will also perform supplier audits, if necessary. You will also participate to health authority inspection.

Who you are

  • Minimum bachelor’s degree in computerized systems and equipment validation
  • At least 5 years of experience in a pharmaceutical / biotechnology environment
  • Knowledge in biotechnology process, cGMP, and health authority expectations
  • Knowledge in GAMP and CSV regulations
  • Knowledge of equipment validation standards
  • Show a desire and motivation to work in Quality and project environment
  • Have a proactive approach to all aspects of Quality
  • Good communicator, dealing directly and efficiently with project teams and global Healthcare Quality Organization
  • Strong analytical and problem-solving abilities
  • Organized and logical in defining workload and delivering projects
  • Fluent in English (written and spoken)
  • French is an advantage
  • What we offer : With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons.

    We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life.

    Join us and bring your curiosity to life!

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