Job Title: IT Validation Specialist
Job Description
This role is critical in ensuring that all IT systems and software comply with regulatory standards, operational requirements, and industry best practices.
The ideal candidate will have a strong understanding of IT validation principles, experience working in a GMP environment, and excellent communication skills.
* Manage the qualification of IT systems, including hardware, software, and infrastructure within a GMP lab setting.
* Validate software applications used in manufacturing, quality control, and other pharmaceutical processes.
* Collaborate with software vendors to ensure system validation documentation is complete and accurate.
* Manage the lifecycle of validated software, including upgrades and decommissioning.
* Perform periodic reviews of validated systems to ensure continued compliance.
* Develop and maintain traceability matrices to ensure alignment with user requirements.
* Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
* Author, review and approve validation documentation, including validation plans, reports, and risk assessments.
* Ensure all validation activities comply with regulatory standards such as GxP, FDA 21 CFR Part 11, and EMA guidelines.
* Prepare validation summaries, deviation reports, and corrective/preventive action (CAPA) plans.
Required Skills and Qualifications
Experience in IT validation, preferably in a pharmaceutical or regulated environment.
Bachelor's degree in Computer Science, Information Technology, or a related field.
Benefits
Our company takes care of its employees with a Total Rewards package. This includes great personal benefits and professional growth opportunities.
We are an Equal Opportunity Employer.