resolving general networking issues. Experience: Extensive IT/Commercial experience gained within a fast-paced environment? Experience of GAMP 5 and working within a GxP environment in providing superior customer service and support. Experience of working within a technical support position, covering Windows, Microsoft Office, Internet Explorer and various business more »
a liaison between operations, QC, IT, third-party vendors, and Engineering to troubleshoot and resolve issues. Ensure that OT systems are maintained according to GxP, GMP, and cybersecurity standards, particularly ISA-95 security principles. Stay ahead of the OT technology roadmap by planning upgrades for legacy systems and ensuring that … and software, ensuring stability, security, and availability across systems. Provide hands-on operational support for OT environments, including setup, configuration, and troubleshooting. Contribute to GxP-compliant system documentation, test plans, and user acceptance testing. Essential Skills and Competencies Operational Experience: 5+ years of experience in IT design, build, and operational … 3+ years in a similar role, supporting systems in a laboratory or manufacturing environment, ideally in the healthcare or pharmaceutical industry. Strong understanding of GxP and GMP compliance in a highly regulated environment. Hands-on experience with IT infrastructure, networking, Active Directory (AD), and Windows operating systems. Technical Knowledge: Knowledge more »
Responsibilities Oversight and Compliance : IT CSV oversight for GXP computerized systems. Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5). Handling deviations, CAPAs, and change controls. Documentation and Review : Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/… process. Flexibility and adaptability in a changing regulatory environment. Education, Experience & Skills Required · Direct experience in leading, managing or participating in CSV projects in GxP environments. · B.Sc. degree in Computer Science, Chemistry, or a relevant scientific field with substantial relevant progressive experience (greater than 3 years). · Extensive experience in … regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, and EU Annex 11 compliance requirements. · GLP/GCP/GMP experience is preferable. · Experience in supporting regulatory inspections. more »
