ICON Warsaw Poland
2 months ago
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Provide validation support specializing in creating, reviewing and providing guidance on validation deliverables such as... validation plan, test scripts, trace matrix, validation summary reports, risk impact assessment, and 21 CFR Part 11 assessment.
• Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Conduct validation activities according to relevant ICON SOP’s and appropriate regulations.
• Create and review key validation documentation such as Risk Impact Assessment, 21 CFR Part 11 Assessment, Validation Plan, Traceability Matrix, and Validation Summary.
• Create, Review, execute formal test scripts and complete associated documentation and ensure test results are reported accurately as applicable.
• Assist in evaluating impact assessment of application changes to determine testing/validation scope.
• Provide guidance to IT team members during project/system implementation and application change management process to ensure adherence to procedure and regulatory expectation.
• Communicate with project team, validation team leader/validation manager/validation leads regarding validation progress and issues
• Complete assigned tasks within budget and timeline constraints and report any quality issues to lead or manager in a timely manner.
• Participates and assists in client audits and regulatory inspections
• Other responsibilities may be assigned as required.
• At least with 3 - 5 years of relevant experience
• Candidates must have working experience with manual testing and preferably also automated testing
• Candidates must have working experience with system development life cycle and creating key validation documentation mentioned above.
• Candidates must have ability to multi-task and be flexible in a fast paced environment. Writing test scripts, executing test scripts, attending stand up calls, and following up with project team on outstanding issues or clarifications.
• Candidates must have ability to assist Validation team members. For example: Providing knowledge or sharing experience. Working with other Validation team members writing and executing test scripts.
• Clinical/Pharma Industry experience with knowledge of regulatory expectations for Clinical systems; GCP Compliance; Audit; 21CFR11 Compliance and related regulations is preferred.
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below
Senior Validation Engineer Warsaw jobs
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