Catalyx Job Title: IT Validation Specialist
About the Role:
This is a key position that plays a pivotal role in ensuring all IT systems and software comply with regulatory standards, operational requirements, and industry best practices.
We are seeking an experienced IT Validation Specialist to join our team working within the pharmaceutical sector.
Responsibilities:
* 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.
Requirements:
To be considered for this role, you should have:
Bachelor's degree in Computer Science, Information Technology, or a related field.
3+ years of experience in IT validation, preferably in a pharmaceutical or regulated environment.
In-depth knowledge of GxP regulations, FDA 21 CFR Part 11, and other relevant standards.
Experience with validation of ERP, LIMS, MES, and other pharma-specific IT systems.
Familiarity with IT infrastructure, database management, and networking in a validated environment.
Excellent problem-solving, analytical, and organizational skills.
Strong written and verbal communication skills, with the ability to present validation results to diverse audiences.
Why Work With Us:
We offer a total rewards package, including great personal benefits and professional growth opportunities.
We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported.
We do not discriminate on the basis of race, colour, religion, sex, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law.
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