Overview
On Site
Full Time
Skills
Test Plans
Incident Management
Risk Assessment
Regulatory Compliance
Security Controls
Computer Science
Life Sciences
GxP
Auditing
Documentation
Pharmaceutics
Manufacturing
Job Details
Responsibilities:
- Develop and execute IT validation activities and documentation, including protocols, test plans, and change controls.
- uthor validation plans, verification reports, and decommissioning documentation.
- Ensure compliance with internal SOPs and external regulations (21 CFR Part 11, 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.
- Bachelor's degree in engineering, Computer Science, or related technical field (preferred).
- Minimum 5 years of experience in computerised system validation within pharmaceutical or life sciences projects.
- Strong knowledge of GxP documentation requirements and regulatory audits.
- bility to create validation documentation independently.
- Familiarity with pharmaceutical manufacturing processes (Fill/Finish preferred).
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