In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.
Responsibilities:
Apply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training. Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies. Facilitate risk assessments to identify validation deliverables and project requirements. Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews. Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports. Analyze validation data and troubleshoot issues in collaboration with technical teams. Maintain communication with stakeholders to address system needs, validation progress, and related concerns.
Requirements:
Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations. Hands-on experience in validating computerized systems. Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance. Ability to work effectively in a dynamic, cross-functional team environment. Proven expertise in applying data governance measures and creating impactful data visualizations. Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation. Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.
