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IT Manager

1 maand geleden

Norway, Nederland Heraeus Medical GmbH Voltijd
About Heraeus Medical GmbH

Heraeus Medical GmbH is a leading global technology group that specializes in medical products for orthopaedics. We are the market leader in bone cement and support orthopaedic surgeons and operating theatre staff worldwide with our proven products and numerous innovations to provide patients with the best possible care.

Job Description

We are seeking an experienced IT Validation Manager to join our IT Validation department. As a key member of our team, you will be responsible for planning, implementing, and documenting computer system validation (CSV) in accordance with the GAMP guidelines. Your primary objective will be to ensure the valid status of our IT systems is maintained.

Key Responsibilities:
  • Creation and precise checking of validation plans, protocols, and reports for accuracy of content and correct implementation of formal requirements for software used internally and across the Group.
  • Supporting audits and inspections, as well as conducting GxP training in various departments.
  • Modeling IT processes/process flows.
Requirements:
  • Degree or training in computer science, natural sciences, or engineering, or a comparable qualification.
  • Experience in the medical device or pharmaceutical environment and in quality management.
  • Knowledge of relevant regulatory requirements, such as GAMP, cGMP, GMP, DIN EN ISO 13485, Quality System Regulations (FDA), and ALCOA.
  • Experience in project, quality, and document management in the context of GxP validation projects.
  • IT understanding and confident handling of MS Office, SAP, SAP Signavio, and Share Point.
  • Good written and spoken German and English skills.
  • Committed and confident team player with excellent communication skills.
  • Flexibility, resilience, and strong organizational skills.
What We Offer

We offer an exciting and challenging work environment with opportunities for further development. Our attractive remuneration package includes a high basic salary, annual one-off payments, and extension of the statutory long-term care insurance to include supplementary long-term care insurance. Additional financial benefits include promotion of private pension provision, life phase account for paid time off, discounts in many online stores, bicycle leasing, and regulated working hours.

We are committed to sustainability and social commitment, with a focus on education, family, and science through our own foundations. If you are curious and motivated, apply now with your documents and reference code 57113 via our online application portal.