IT Validation Manager

4 weken geleden


Duitsland, Nederland Heraeus Medical GmbH Voltijd
IT Validation Manager

At Heraeus Medical GmbH, we are seeking a highly skilled IT Validation Manager to join our team. As a key member of our IT department, you will be responsible for ensuring the validity of our IT systems, adhering to GAMP guidelines and regulatory requirements.

About the Role
  • Plan, implement, and document computer system validation (CSV) in accordance with GAMP guidelines.
  • Create and review validation plans, protocols, and reports for accuracy and compliance.
  • Support audits and inspections, and conduct GxP training in various departments.
  • Model IT processes and process flows to ensure seamless operations.
Requirements
  • Relevant degree or training in computer science, natural sciences, or engineering.
  • Experience in the medical device or pharmaceutical environment, with a focus on quality management.
  • Knowledge of relevant regulatory requirements, such as GAMP, cGMP, GMP, DIN EN ISO 13485, and Quality System Regulations (FDA).
  • Strong IT understanding, with proficiency in MS Office, SAP, SAP Signavio, and Share Point.
  • Excellent written and spoken German and English skills.
What We Offer
  • Exciting tasks with high personal responsibility in a dynamic environment.
  • Attractive remuneration, including a high basic salary, annual one-off payments, and extended long-term care insurance.
  • Additional financial benefits, such as promotion of private pension provision and discounts in online stores.
  • Regulated working hours, mobile working, and time off in lieu for overtime.
Apply Now

Send your documents with the reference code 57113 via our online application portal.

Any questions? Our recruiting team will be happy to help you by email: recruiting.hme@heraeus.com.


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