Senior Consultant - Computer System Validation
MAM GruppePosted on 14/Nov/2019
- IT Security
- Frankfurt, Germany
- 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).
- 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.