ERGOMED

QA Engineer

• Ensures continuous quality improvement through effective management and oversight of Audits and Inspections
• Facilitates ongoing quality improvement measures through communication of audit & Inspection intelligence and compliance guidance/training
• Leads, educates, mentors, and develops the team within the function to ensure their competence and confidence in developing to become subject matter experts
• Ensures that reporting, review and analysis of Findings from Audits and Inspection and CAPAs is performed efficiently and in compliance with global regulations, legislation and PrimeVigilance requirements
• Manages and maintains the electronic quality management system (EG-QMS) Audits module -CAPA Management
• Performs periodic trending of Findings across the company, providing insights into the potential causes of trends to operational and quality management
• Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team
• Participates in audits and inspections, including document request provision, front and back-room activities, and follow-up of audit and inspection findings and completion of client questionnaires and RFP/RFI
• Acts as a Subject Matter Expert and client point-of-contact for Quality including attendance at operational and quality governance meetings
• Collaborates and guides operational personnel to ensure effective root cause analysis and writing/delivery of appropriate CAPA Plans and develops and delivers training on these topics and other quality topics
• Generates metrics on CAPA compliance
• Assists in the development, maintenance and management of mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, US FDA CFRs, JMPA and ICH-E6
• Procedural creation, management revision

Senior Quality Assurance Manager

Clinical Research

• Initiates, coordinates and develops strategic plans and sales strategies within a specified territory or accounts.
• Develop account strategies & implementation plans and expand through accounts
• Identify new markets and research new business opportunities, identifies likely sales points within a specified territory or accounts
• Collect critical information for proposal preparation and provide detailed input and leadership of the proposal process for each opportunity initiated
• Prepare and organize sponsor presentations
• Facilitate the preparedness of the team in attending any client meetings. For example, Capabilities meetings or Bid Defence Meetings (BDM)
• Coordinate and monitor any budget or contract negotiations, post award of any work, within a specified territory or accounts.
• Interact with operations, keeping track of study status for projects with sponsors and help coordinate change orders when notified of a change of scope by operations.
• Establish and maintain regular contact and an excellent rapport with future and current clients.
• Monitor and track competitor CRO activities
• Plan and attend major industrial events and tradeshows

Senior Quality Assurance Manager

Business Development Director – Clinical Research