IT CSV Expert

Leading computer systems validation and infrastructure qualification in IT Department.
 

• Leading computer systems validation and infrastructure qualification in IT Department.
• Forming and managing IT Computer Systems Validation team, setting team priorities and meetings, organizing the work to make the most effective use of working time and task execution, monitoring the status of ordered tasks ensuring compliance with applicable FDA regulations.
• IT CSV demand management, resource planning, strategies and schedules.
• Supervision of updating documentation and / or project tracking tools as needed.
• Supervision and/or development of the main validation and qualification documentation.
• Participation in preparations for and in the inspections of pharmaceutical regulatory authorities.
• Participation in the development and updating of procedures and documentation templates as part of validation of computerized systems and qualification of IT infrastructure.
• Contribute to the optimization of validation processes.
• Sharing validation knowledge.

• 5 years of professional experience in the biotechnology or pharmaceutical industry in the computer system validation or similar role.
• Practical knowledge of software validation and infrastructure qualification.
• Excellent knowledge of FDA requirements and current guidelines for validation and qualification in the biotechnological/pharma industry.
• Experience in keeping process and project documentation.
• People management experience.
• Fluent English, both writing and speaking.
• Ability to identify and solve problems independently.
• Very good knowledge of MS Office.
• It is preferable to have higher educational qualifications in Computer Science, Engineering, or other technical related fields.

• Private healthcare.
• Life insurance.
• Pension plan above national standards.
• Relocation package.
• International work environment.
• Additional free day.
• and more…