Life Science Consultant, Software Quality Engineer (SQE)

le contenu du travail

• Coordinate and execute quality related activties to ensure all computerized system requirements are compliant with regulations (GxP/non-GxP, CSV, Privacy, SOX), industry standards and client quality management system
• Use scientific expertise to increase computerized system quality reliability, value of available recources, process efficiency
• Assure fit for purpose of mathematical algorithms and formulas used in different computerized systems.
• Understand different computerized system architecture and what each component is doing
• Ensure that IT suppliers comply with quality standards and requirements.
• Perform regular supplier audits and assessments, establishing schedules for reviewing quality performance, to ensure compliance and improve processes.
• Identify technical problems, report on compliance issues, define recommendations and implement corrective actions
• Monitor, communicate and improve KPI’s
• Establish specific short/long term quality goals.
• Provide leadership by establishing clear expectations and demonstrating high standards of work practices.
• Update job knowledge by participating in educational opportunities, reading professional publications, maintaining personal networks and participating in professional organizations.
• Develop and implement processes to ensure compliance with quality management systems, and continual process improvement.
• Complete training on relevant quality procedures om time
  

• Industry Knowledge-Possess strong understanding of quality engineering best practices, particularly in Life Science and Healthcare Industry; monitor updates and trends and use industry knowledge to advance the organization.
• Technical Expertise- Ability to exhibit functional knowledge of R&D, manufacturing production, Commercial etc.; bring unique professional experience and maintain current certifications and licenses.
• Team Player- Ability to understand the role of your team members within the larger company structure and effectively communicate and collaborate with other members of the organization.
• Results Orientation-Ability to maintain focus on short and long term goals, value outcomes and produce results.
• Computerized System Understanding- Knowledge of (cloud) technologies, business processes, quality, and costs to maximize value within the project
• Problem Solving and Decision Making-Ability to identify problems, compile information to solve them, act decisively and show good judgment.
• Organizing and Planning- Possess strong organizing and planning skills, manage time, effectively prioritize multiple tasks to maximize efficiency and productivity.
• High Standards- Ability to establish and maintain standards and attention to detail that guarantee quality and continuous improvement.
• Initiative- Ability to be proactive, see what needs to be done, and make things happen; take personal responsibility to act.
• Effective Communication-Ability to clearly articulate information through conversation, phone calls, email, written reports and other documents.
• Learning Agility-Ability to learn quickly and use new information effectively.
  

• Scientfic University degree (Bachelor, Master, Phd) in engineering, mathematics, statistics or related field required.
• Experience in a quality management, control, assurance.
• Advanced understanding Life Science and Healthcare Quality Standards and requirements.
• Advanced interpersonal skills, along with the ability to communicate effectively and maintain credibility with customers, suppliers, and across all levels in the business.
• Superior problem solving, detailed oriented and analytical skills; demonstrated passion for solving problems and operational excellence.
• Strong writing, organizational and communication skills.
• High level of proficiency with tools; including Microsoft Office (Excel, SharePoint), Jira, MS Azure, HP ALM, etc.
  

• Flat hierarchies and responsibility from the beginning
• People-oriented culture
• Diversity and inclusion focused environment
• Global client projects in a multinational environment
• Flexible working hours and home-office
• Involvement in global conferences
• Individual professional development, training and coaching
• Unlimited full employment contract
• Excellent remuneration package consisting of a competitive salary plus a substantial bonus