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MAM Gruppe work solely with top-tier clients seeking talented candidates to fill their positions. View the job roles below and let us begin the next steps towards elevating your career.

Senior Consultant - Computer System Validation

MAM Gruppe
Posted on 14/Nov/2019
  • IT Security
  • Full-Time
  • Frankfurt, Germany

Description

Your tasks

  • Competent, timely and cost-effective, independent management and implementation of parallel computer validation projects including the preparation of offers and project budgets.
  • Development of validation concepts (e.g. validation master plans) taking into account the legal requirements.
  • Creation of computer system validation documents e.g. execution and evaluation of risk analysis. 
  • Sub-project management for validation activities including budgeting, cost, and deadline tracking, including active control of internal project staff and external consultants. 
  • Ensuring quality assurance in projects.
  • Coordination and implementation of internal and external training. 
  • Execution and documentation of supplier audits.
  • Ensuring compliance with regulatory requirements (compliance). 

 

Your profile

  • Completed natural science or economics studies or equivalent experience.
  • At least 5 years of professional experience in computer system validation.
  • Excellent knowledge in quality management, combined with very good knowledge of the following regulations/processes: GMP, FDA, quality management, ITIL.
  • Several years of experience in the creation, maintenance and use of documents in the validation environment.
  • Routine practice in conducting training and presentations.
  • Very secure handling of Microsoft Office and ideally with document management systems.
  • Experience in project management desirable.
  • Knowledge of SAP is ideal. 
  • High cost awareness, implementation and decision strength as well as goal-oriented action.
  • Very good analytical and conceptual skills, high problem-solving skills and communication skills.
  • Strong customer, service and team orientation. 
  • High degree of initiative and dedication.
  • Very good German and English skills, both spoken and written.