Expert- IT Qualification
2 weeks ago
Work Your Magic with us
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimageable with us.
**Qualification and Validation Expert - R&D**
The Healthcare (R&D, GHO, M&S) Application team supports the delivery of the healthcare systems service Portfolio for the HealthCare Research (Global Discovery Technology, Global Early Development, External Innovation, Patents & Scientific Services) and Development (Strategic & Business Operations, Global Clinical Development, Global Regulatory Affairs & QA, Global Medical Affairs & Safety).
**Responsibilities**:
- Preserve the qualified state of the IT Infrastructure component all over its lifecycle and Validated state of the computerised system
- Create and maintain the qualification and Validation documents, as appropriate;
- Responsible for managing the progress of the qualification, about the plan, in close contact with the IT Service Provider and the Service Delivery Manager
- Support the on-going regulatory compliance of the IT components for defined services;
- Review and approve regulatory system changes and documentation;
- Responsible for the operational tasks of IT Quality Assurance including audit responsibility;
- Conduct periodic review(s) as part of the periodic review of the entire system and compile related reports during operation phase;
- Be the accountable point of contact in matters associated with the qualification.
**Minimum Qualifications**:
- Minimum of 7 years of experience
- Previous experience in the biotechnology / pharmaceutical or related industry implementing and validating computer systems that manage regulated information
- Working knowledge of IT infrastructure qualification processes and IT operating procedures
- Knowledgeable in 21 CFR Part 11, GCP and GLP regulations Thoroughly familiar with Quality & GxP IT compliance requirements
- Excellent analytical skills sufficient to lead complex problems resolution, make accurate and consistent interpretations and present high-level reporting for weekly operations meetings and monthly service reviews.
- Excellent written and verbal communications skills
- Working knowledge of information security and best practices
- Proven fast learning & problem management skill
**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress
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