
IT Specialist for Laboratory Applications
2 weeks ago
IT CSV Consultant
">Description:We are seeking an IT CSV Consultant to join our team. As an IT CSV Consultant, you will ensure secure operation, integration, and qualification of laboratory applications for our clients.
">Key Responsibilities:- Proficient in handling and configuring laboratory applications such as Tiamo, HPLC, Endoscan, TOC, and SOLOVPE.
- Skilled in executing data migration tasks, including backup, and archiving processes, ensuring data security and compliance.
- Basic understanding of network systems, including firewalls, DNS, IP management, and cable patching.
- Experienced in software configurations, including PC setups per in-house IT requirements and remote desktop tools like Dameware.
- Skilled in PC imaging using tools such as Acronis or Macrium to ensure efficient system recovery and deployment.
- Competent in identifying and responding to cybersecurity threats, collaborating with Cybersecurity teams to address potential security breaches or lockouts.
- Experienced in executing job plans such as audit trail reviews, user access reviews, manual password resets, and critical settings verification in line with Data Integrity Assessments (DIA) or security assessments.
- Skilled in managing and coordinating with stakeholders for task reviews and successful project execution.
- Adept at supporting cross-functional teams, fostering collaboration, and achieving shared objectives across technical and operational domains.
- Draft and review design and qualification documentation.
- Experience in paperless validation systems and document management systems.
- Execution experience in commissioning and qualification processes.
- Knowledge of 21CFR Part 11 and GAMP 5 categories.
- IT CSV experience in a pharmaceutical or GMP environment.
- Bachelor's or Master's degree in Engineering, Control System / Computer Science / Information Security, or a related field.
- Incident Management: Conduct root cause analysis and contribute to post-incident reviews, ensuring corrective actions and improvements in security measures.
- Troubleshooting: Resolve complex technical issues while maintaining compliance with CSV practices.
- Impactful Projects: Consulting roles with international healthcare clients on strategically significant projects.
- Professional Environment: Work within a motivated team in a professional consultancy setting.
- Leadership Opportunities: Take on leadership roles and contribute to shaping our organization.
- Career Development: Excellent opportunities for career advancement within a leading consulting firm.
- Training & Mentoring: Structured training programs and peer mentoring to support your professional growth.
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