IT Validation ConsultantKatalyst HealthCares & Life Sciences • Raleigh, NC
IT Validation Consultant
Katalyst HealthCares & Life Sciences • Raleigh, NC
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job_description.job_card.job_descriptionBachelor's degree in engineering, Computer Science, or related technical field (preferred). Minimum years of experience in computerised system validation within pharmaceutical or life sciences projects. Strong knowledge of GxP documentation requirements and regulatory audits. Ability to create validation documentation independently. Familiarity with pharmaceutical manufacturing processes (Fill / Finish preferred).
Responsibilities :
- Develop and execute IT validation activities and documentation, including protocols, test plans, and change controls.
- Author validation plans, verification reports, and decommissioning documentation.
- Ensure compliance with internal SOPs and external regulations ( CFR Part , GxP, etc).
- Participate in investigations of validation deviations and implement corrective actions.
- Support IT system lifecycle activities, including maintenance, incident management, and risk assessments.
- Conduct system reviews to ensure compliance and security controls are in place.
Requirements :
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