System Validation Expert

Helion IT
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System Validation Expert

KAR 2015

  • 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.

Your challenge
We are looking for an enthusiastic contingent worker in the area of System Validation Expert with experience in Business Quality Management Systems (ISO 13485) and FDA (21CFR) regulations within an international environment?

Your responsibilities

  • 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 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

Your team
You are part of the Q&R– PQMS capability and working in the area CL Personal Health Businesses. You will be part of the CL Business Management System team existing of 5 persons dealing with activities like Quality Management, System Validation, Training, CAPA and Change Control.

Our offer
We welcome you to a challenging, innovative environment with great opportunities for you to explore. The offer will be based on a temporary contract (0.6 fte) till mid of 2016.

We are looking for

Our ideal candidate has the following profile criteria

  • 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




3 tot 6 maanden



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