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.
...Earn up to $4,500 Weekly | Drop & Hook Brown Trucking is hiring CDL-A Owner Operator Drivers . Enjoy reliable home time, strong weekly pay, and a company built around supporting drivers for long-term success. CDL-A Owner Operator Driver Highlights Drivers earn...
...Job Description Job Description JENNMAR Services is currently seeking a Bolter/ Driller/ Underground Operator for an Aggregate Mine in the Southwest, PA area. These are full-time positions with competitive salary and benefits available. Benefits forBolter/ Driller...
...Brightmind Ventures, IA Ventures and other top firms. Role Origin is seeking a Sales / Business Development Representative (SDR / BDR) who thrives when challenged, combines competitive energy with focus, builds meaningful connections, and is motivated by measurable...
...employees whom are timely, professional and driven to succeed. If this sounds like you, then I can't wait to hear from you! We are felony friendly (a second chance company,) and we also provide transportation to and from the job site! Felons are encouraged to apply!...
...Job Description Equities, Options & Fixed Income \n Remote | Full-time \n Corgi is recruiting experienced institutional sales traders with established client relationships to grow our business across US equities, options, fixed income and international markets...