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 »
experience in Quality or Process management within the Medical Technology &/or Pharmaceutical industries. Experienced in IT Cloud Applications & their functionality. Ideally experienced with TrackWise Digital (or Salesforce). Any experience in dealing with Computer Systems requiring Validation is considered advantageous. Your Profile: Completed University Degree in Computer Science 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 »
/or within a quality/compliance/regulatory organization in an FDA regulated business preferred. US FDA Medical Device Reporting and experience with Trackwise Digital preferred. Work Environment: This is largely a sedentary role. This job operates in a professional office environment and routinely uses standard office equipment. more »
materials. • Maintains adequate inventory of media and materials required for testing. • Initiates proper documentation upon discovery of deviations and out of specification results, completes Trackwise write-up for deviations and out of specification results. • Performs special projects as assigned including testing, compiling and trending of data and report generation. … support company goals. • Reviews laboratory logbooks to ensure compliance with good documentation practices. • Releases manufacturing areas after recovery using the ASCN in Trackwise. Writes Trackwise notifications and deviations and completes CAPAs. Creates and completes Trackwise change controls. Writes and revises SOPs, forms, risk assessments and other controlled documents. more »
reputable company with great training, a positive and open culture with a family feel then apply today!!!. Duties Sophisticated document control required using TrackWise To undertake work related to Quality Assurance objectives. maintain contact with personnel at all levels within to ensure that documents are prepared accurately and … equipment logbooks and laboratory notebooks. Attribute: Thorough, meticulous with impeccable attention to detail Self-starter able to prioritise and take ownership workload IT literate – Trackwise experience could be preferred but not essential Ability to see tasks through accurately from beginning to end Collaborative individual able to engage with individuals more »
