Freelance System Validation Expert

SIRE Life Sciences
Geplaatst op
Binnen een jaar
Op locatie


Our client is a professional Healthcare and Medical Devices organization, based in Noord-Brabant Netherlands.

My client is a multinational medical devices company, operating from the Netherlands.

Computer System Validation is the technical discipline that Life Science companies use to ensure that each Information Technology application fulfills its intended purpose. You will be in charge of taking care of the validation and make sure the systems with the QMS are working correctly.

You will be in charge of the executing of Software Validation and Control Activities. You will be in charge of ensureing the accuracy, completeness and compliance of the Software Validation deliverables by reviewing the Software packages of the applications, which are integrated in the QMS. Giving the results of the validation you will be the person responsible for giving feedback and advise on adjustments. You will be in charge of the CAPA's which will follow from non product Software systems. Measuring efficiency and effectiveness of the QMS Software Validation. Collaboration with the IT department to ensure software control methodologies are implemented for application control.

· Minimum 7-10 years of experience in validation of computer systems
· Experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5
· Minimum of 7 computerized systems implementations, comprised of multiple application types, in a regulated environment · Thorough knowledge of validation principles (including IQ, OQ, and PQ)
· Demonstrated ability to interact and communicate (both oral and written) with junior project team/ organizational members, business leaders and senior executives. · Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections
· Ability to apply current inspectional techniques to project documentation during the system lifecycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained. · Effective judgment and decision making skills, typically made under stressful situations
· Competency in project management and the execution of multiple projects
· Demonstrated capability in critical thinking and leadership with strong abilities in relationship management
· Fluent in English

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