Life Science Consultant, Software Quality Engineer (SQE) - Vaucluse
Capijobnew Vaucluse
Job Functions 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 Qualities & Attitude 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. Experience & Qualifikation 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.
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 Qualities & Attitude 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. Experience & Qualifikation 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.
We offer great benefits 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
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