Seeking an IT Validation Expert to ensure seamless integration of technology systems and software in a GMP lab setting.
The ideal candidate will possess a strong background in IT Infrastructure, computer system validation (CSV) and regulatory compliance with prior experience in a pharmaceutical or highly regulated environment.
Key Responsibilities:
* Manage the qualification of IT systems, including hardware, software, and infrastructure.
* 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.
* 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).
Required Skills and Qualifications:
* 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.
Why Choose This Role?
This is an exciting opportunity to join a dynamic team and contribute to the advancement of customer operations.
Benefits Include:
* A competitive salary and benefits package.
* Opportunities for career growth and professional development.
* A supportive and inclusive work environment.
Equal Opportunities Employer
We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported.