System Validation Expert
For one of our leading tech clients we are urgently looking for a System Validation Expert for a minimum 3 to 6 month contract in Holland – North Brabant.
The successful System Validation Expert will have experience in Business Quality Management Systems (ISO 13485) and FDA (21CFR) regulations within an international environment dealing with activities like Quality Management, System Validation, Training, CAPA and Change Control in addition to the following responsibilities:
Maintain the validation state of 9 global tools (perform Quality reviews on update Validation Files).
The global software inventory needs to be re-assessed (setting the risk rating based on the QSIA + VSE). Ensure the local entities have completed the local software inventory.
Participate as Business Process Expert (BPE) in the End2End Software Validation Program
Strengthen the connection with IT to ensure the CL Validation Master Plan is established.
Define and establish a lean practice ( tools, methods, standards, competency, process and process performance) for SW validation & lifecycle control of new and existing SW systems
Execute and /or manage SW validation & control activities
Ensure the accuracy, completeness and compliance of SW validation deliverables by reviewing the SW validation packages of SW applications which automate Quality Management System processes
Author, review and/or approve SW validation deliverables for non-product SW, including but not limited to SW validation plans, requirements, test plans/protocols/results, risk assessments, traceability matrix and summary reports
Provide guidance/feedback to with respect to applicable regulatory requirements and HealthTech policies and procedures
Recommend and lead corrective and preventive actions (CAPAs) related to non-product SW system intended function
Establish, monitor and respond to metrics on the efficacy and efficiency of the QMS SW Validation and Control activities and its ability to support the business
Align with IT to ensure software control methodologies are implemented for application control including inventory management, change management and configuration management
Keep track and influence SW Compliance & Control practice developments
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.
Competency in project management and the execution of multiple projects
Fluent in English – Dutch would be a plus
3 – 6 Months with likely extension
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