Due to an increase in Computer System Validation projects, we are looking for an external.
The project is about the Implementation of the implementation of the new laboratory automation system designed to meet all the international standards and requirements of the main international regulatory agencies such as ANVISA, FDA and EMA and accordance with internal regulations.
Duties will include :
• Develop project specific Computer System Validation approach
• Prepare project CSV deliverables according to all the international standards and requirements of the main international regulatory agencies such as ANVISA, FDA and EMA, all documents will be reviewed and approved by BI in accordance with BI internal standards.
• Creation of a validation plan and report
• Creation of the Change Control Requests
• Definition of the validation and testing strategy
• Performance of Computer System Validation (creation and or review of the user requirements specification, functional specification, configuration specification, risk and impact analysis, test plans, test strategy, test cases, test reports or any other document created by the testing team)
• Creation of validation discrepancy summary, if applicable
• Management and coordination of validation activities with internal departments, external contractors and suppliers
• Creation of validation Standard Operating Procedures (SOPs)
• Prepare and deliver cross functional training in system specific validation methodologies and related procedures to facilitate validation activities
• Consulting on data integrity for computer system validation
• Diploma or master’s degree (MBA, MSC) with major focus on IT, engineering, sciences, Pharmaceuticals and/or Biotechnology or equivalent and longstanding professional experience in regulations and processes
• Knowledge of GxP regulations, CSV&C and quality regulations/guidelines (e.g. EMA/Europe, FDA/USA, Anvisa/Brazil, CFDA/China, ICH, WHO) and in data integrity
• Deep understanding of IT trends and technologies with the experience how to bring and establish innovations into the business
• Project Management skills in a complex international environment of multiple projects
• Effective team player and ability to work in a rapidly changing environment
• Proficient communication skills in English (verbal and written), skills in German would be an advantage
• At least 8-10 years experience in similar projects
• Experience in Project Management
Start: January/ February 2022
End: July 2022
Workload: full-time (100% Remote)
For further information please contact Mr. Roman Sperling.