IT Validation Manager

3 weken geleden

Duitsland, Nederland Heraeus Medical GmbH Voltijd
IT Validation Manager (m/f/d)

Location Wehrheim
Permanent
Full-time

About Heraeus Medical GmbH

Heraeus Medical GmbH 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. Our goal: Bringing Joy back to Patients' Lives. How do we achieve this? Through a culture of openness and curiosity, lived by our employees worldwide.

Key Responsibilities:
  • Support the planning, implementation and documentation of computer system validation (CSV) in accordance with the GAMP guidelines and help ensure that the valid status of the IT systems is maintained.
  • Create and precise check validation plans, protocols and reports for accuracy of content and correct implementation of the formal requirements for software used internally and across the Group.
  • Support audits and inspections and conduct GxP training in various departments.
  • Model IT processes / process flows.
  • Cooperate with relevant departments and other Heraeus divisions, also worldwide.
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 the relevant regulatory requirements such as GAMP, cGMP, GMP, DIN EN ISO 13485, Quality System Regulations (FDA), 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:
  • Exciting tasks - implement them with a high degree of personal responsibility in an ambitious environment with very good opportunities for further development.
  • Attractive remuneration - high basic salary in accordance with the collective agreement for the chemical industry, annual one-off payments (vacation pay, Christmas bonus, future payment) and extension of the statutory long-term care insurance to include supplementary long-term care insurance.
  • Additional financial benefits - promotion of private pension provision, life phase account for paid time off (e.g. sabbatical, early retirement), discounts in many (online) stores, bicycle leasing.
  • Regulated working hours - 37.5 hours per week, mobile working, time off in lieu for overtime, retirement leave, 30 days annual leave, special leave for special occasions.
  • Health & well-being-company medical service with comprehensive check-ups, social counseling and in-house staff canteen with freshly prepared meals every day.
  • Sustainability and social commitment-Sustainability as part of the corporate strategy and targeted promotion of initiatives in the areas of education, family and science through our own foundations.
Apply Now

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

Any questions?

Our recruiting team, Heraeus Medical, will be happy to help you by email: recruiting.hme@heraeus.com. Or visit us at

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