Worthing, England, United Kingdom Hybrid / WFH Options
Hobson Prior
linked to GxP impact and GxP compliance of IT systems and impact assessment of pertinent change controls. Any other assigned duties. Requirements: Experience with TrackWise, LIMS and Documentum and/or any other QMS systems. Acquaintance global GxP, e.g., FDA CFRs, EU, 'Third countries' other than the UK. Familiarity more »
Basic statistical tools proficiency. Excellent report writing and attention to detail. Proficiency in Word and Excel. Preferred Qualifications & Experience: Familiarity with QMS systems like TrackWise, LIMS, Documentum. Knowledge of international GxP regulations. more »
improvements Coordinate QMS training for site employees and ensure this adheres to current regulatory requirements Maintain responsibility as the site system owner for the Trackwise electronic QMS Support and track regulatory findings and trends that may lead into a focus of regulatory inspections Act as Single Point of Contact more »
preparing and reviewing data and reporting trends and findings as necessary. Perform routine quality reviews of equipment. Receive, review and process quality reports on TrackWise Investigate OOS records in coordination with SMEs, and ensure the timely progression of reports. Participate in internal and external audits. QMS administration activities. What more »
in leadership and organisation by Microsoft (Word, Excel, Outlook, and PowerPoint). of managing audit results (non-conformities) and clinical service provider management using Trackwise (or a comparable electronic system). Contact details to apply today: +441293778666 gjohnstone@barringtonjames.com more »
assessments, providing general guidance on how to interpret standards and regulations. and support clear and concise rationales to support the Technical impact assessments. the TrackWise process for new/revised standards and regulations including follow up on implementation of changes. regulatory key processes requiring certified testing by a test more »
