Senior Specialist - Qualification Owner
Senior Specialist - Qualification Owner
merck healthcareThis job is no longer accepting applications
Job Description
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.
Your Role
Apply now and become a part of our diverse team!
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.
Your Role
- Lead the design and implementation of document management infrastructure solutions aligned with company's digital strategy.
- Provide expert consultation on infrastructure setup for on-premises and cloud-based document management systems.
- Ensure adherence to GDP, GxP, and other relevant regulatory requirements for all document management infrastructure.
- Assess and recommend appropriate hosting models and infrastructure solutions for document management applications.
- Develop and maintain comprehensive technical documentation for infrastructure configurations.
- Collaborate with IT, Quality, Regulatory, and business stakeholders to align document management infrastructure with business needs.
- Demonstrate strong technical leadership by guiding teams and providing direction on infrastructure matters while effectively communicating complex technical concepts to various stakeholders.
- Possess excellent problem-solving abilities, manage infrastructure projects from conception to implementation, and lead changes with minimal disruption to the business.
- Bachelor's degree in computer science, Information Technology, or a related technical field, along with a minimum of 10 years of experience in IT infrastructure management
- Industry Knowledge: Experience in IT, pharmaceutical, life sciences, or regulated industries preferred
- Infrastructure Expertise: Experience with on-premises infrastructure setup, cloud infrastructure deployment (AWS, Azure, GCP), hybrid cloud architecture, and Infrastructure as Code (IaC) principles.
- Document Management Systems: Experience implementing and supporting enterprise document management solutions.
- Virtualization: Experience with virtualization technologies and containerization (VMware, Docker, Kubernetes).
- Candidates should possess knowledge of infrastructure security best practices and compliance requirements, along with a strong understanding of network architecture to ensure secure document management systems.
- Understanding of GxP and GDP principles, along with regulatory requirements for document management systems, and possess expertise in implementing infrastructure that supports these compliance standards effectively.
- Validation: Experience with computer system validation in regulated environments.
- Risk Management: Ability to assess and mitigate infrastructure-related risks in compliance with regulatory requirements.
- ITIL certification.
- Regulatory compliance certifications relevant to the pharmaceutical industry.
Apply now and become a part of our diverse team!
More Info
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Key Skills
cloud infrastructure deployment
infrastructure security best practices
hybrid cloud architecture
virtualization technologies
on-premises infrastructure setup
GDP
enterprise document management solutions
