IT Support and Csv Officer
Il y a 4 mois
**GC Corporation** was founded in 1921 in Japan and has developed itself into one of the most prominent companies in the development, production and distribution of a very wide range of dental products. Since 1972 GC Europe NV, our European Headquarter is located at the Researchpark Haasrode in Leuven. **GC Europe NV** supports and leads our different sales offices and dealers. Our warehouse spreads our products to Europe and the Middle East. Next to this we produce some leading products for dental technicians.
**We are currently looking for a**:
**IT Support and CSV Officer**
**Purpose of the job**
As a CSV expert in the pharma/medical device environment, you will plan, write, implement, and review the computer system validation (CSV) protocols in place. This highly specialized role ensures that the computerized system for GxP (good practice regulations and standards) operates as intended and meets regulatory requirements. In such a highly regulated industry as pharma/medical device, you need to ensure that the required documentation to back this up and demonstrate compliance is correct and complete. Your role and responsibilities as a CSV expert are likely to combine tasks such as supporting, proposing and implementing improvements with reviewing, maintaining, and updating key documentation/equipment in accordance with current regulatory requirements.
**Main Responsibilities**:
- Provide technical support to users and resolve IT-related issues: Provide prompt and effective technical support to users, resolving their IT problems and ensuring their satisfaction. Document solutions and best practices to enhance knowledge-sharing and problem-solving efficiency.
- Design, plan, and implement IT infrastructure solutions, including servers, storage, networks, and virtualisation: Collaborate with stakeholders to understand their needs and requirements, translate them into technical specifications, and design and implement the appropriate IT infrastructure solutions.
- Manage and maintain Windows Server systems, including Active Directory, DNS, and DHCP: Effectively manage and maintain Windows Server systems, ensuring they are secure, up-to-date, and functioning optimally. Configure and troubleshoot Active Directory, DNS, and DHCP services to support the overall network infrastructure.
- Configure and manage Azure cloud services, including virtual machines, storage, and networking: Utilize Azure cloud services to provision, manage, and optimise cloud-based infrastructure resources. Implement cloud-based solutions that align with business objectives and enhance IT agility.
- Manage and track project timelines, resources, and budgets: Effectively manage project schedules, allocate resources, and adhere to budget constraints to ensure successful project delivery.
- Identify and implement security measures to protect our IT infrastructure: Conduct regular security assessments to identify and mitigate potential threats. Implement appropriate security measures, such as firewalls, intrusion detection systems, and access controls, to protect the organization's IT assets.
- Document IT infrastructure configurations and procedures: Maintain comprehensive documentation of IT infrastructure configurations, procedures, and troubleshooting guides to ensure clarity, accessibility, and continuity of operations.
- Partner with other regions and GCIAG (Global) to contribute to global standards and solutions and implement local initiatives aligned with the global strategy, midterm and long term plan.
- Stay up-to-date on industry trends and technologies: Continuously research and stay abreast of emerging IT trends, technologies, and best practices to ensure the organization's IT infrastructure remains cutting-edge and secure.
**Main responsibilities**
**CSV Specialist**
- Documentation - writing, maintaining, reviewing, and updating validation documentation and approving validation SOPs.
- Support validated equipment’s
- Issuing test plans and test protocol execution.
- Reviewing validation data, compiling reports, and contributing to internal audits and external inspections as they arise.
- Proposing and implementing process upgrades and efficiency improvements.
- Keeping on top of advances in the field and updating to regulatory requirements.
- Training staff on the computerized systems in line with the relevant protocols and regulations.
**Additional Responsibilities**
- Troubleshoot and diagnose equipment for emergency repairs and carry out preventive maintenance routines. Setup coordination for complex systems and conduct inspections with guidance.
- Provide initial fault isolation and propose resolution for approval by more senior colleagues to limit and address issues promptly.
- Contribute to reviewing existing operations in their work area and generate new ideas to help identify continuous improvements.
- Develop knowledge and understanding of the organization’s policies and procedures and of relevant regulatory
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