Job-ID32840630Reference26-01428 Job Description: 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.
...We are partnering with a well-established manufacturing organization to identify a Plant Manager to lead operations at a growing West Michigan manufacturing facility. This leader will oversee approximately 150 production and office employees and will have broad responsibility...
Applications will be accepted beginning Tuesday, June 23, 2026 12:00 AM (Mountain Standard Time).Special Education Coordinator Rock Point School, Inc. dba Rock Point Community School seeks a Special Education Coordinator in Rock Point, AZ.Location of Employment Highway...
This Is Caregiving-Done Differently.This is a caregiver position with a unique focus on activity-based dementia care. While you'll provide supportive caregiving as needed, you'll also spend much of your day helping clients stay active, engaged, and connected through meaningful...
...technology and talent are unstoppable together. And we're just getting started.Join us to put AI to work for people.Job DescriptionCEG AMS Partner Portfolio Excellence Lead Job Description The Role The CEG Americas (AMS) Partner Portfolio Excellence Lead owns the...
A regional education consultancy is seeking a qualified professional to coordinate communication and resources in education. This role involves providing coaching and professional development, designing training programs, and evaluating educational effectiveness. Candidates...