
Chief IT Specialist
2 days ago
Job Title:
">Ensure alignment with corporate IT standards and regulatory requirements.">Provide GxP-compliant support for manufacturing systems (MES, LIMS, SCADA, etc.) and ensure proper documentation and validation protocols are followed.">Act as the primary IT contact for plant and quality assurance teams.">Support audits and inspections by regulatory bodies (FDA, EMA, etc.) by providing required documentation and demonstrating compliance.">Manage local infrastructure (servers, networks, desktops, printers) and coordinate with central IT teams for enterprise-level support.">Implement and monitor cybersecurity protocols in the plant environment.">Coordinate the rollout of new IT systems and upgrades while ensuring minimal disruption to manufacturing operations."> Maintain and update IT SOPs in compliance with GxPstandards.">Collaborate with vendors and third-party service providers for support and maintenance of plant systems.">">Qualifications & Skills:
">">Bachelor's degree in computer science, Information Technology, or related field.">3+ years of IT experience, with at least 2 years in a pharmaceutical manufacturing environment.">Strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements.">Experience supporting or managing systems such as MES, LIMS, SCADA, or ERP in a GMP environment.">Familiarity with ITIL processes and system validation life cycle (SDLC).">Strong troubleshooting, analytical, and communication skills.">Ability to manage projects and coordinate cross-functional teams.">Experience with audit readiness and participation is a strong advantage.">-
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