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Quality Assurance Engineer IT systems (f/m/d)
LongTaal, s. r. o.
Place of work
Remote work
Remote work
Contract type
full-time
full-time
Start date
October 2020
October 2020
Wage (gross)
2 000 EUR/monthPerformance-based bonuses
2 000 EUR/monthPerformance-based bonuses
Information about the position
Job description, responsibilities and duties
Our client Science 37 has developed a cloud based clinical research platform that is used by both external and internal staff to run distributed clinical trials. Your success as a Quality Assurance Engineer will be evaluated based on your ability to support quality compliance operations for the clinical research platform. Responsible for ensuring the overall compliance for GxP systems developed/utilized at Science 37.
Duties include but are not limited to:
• Assure quality systems are followed and integrated with business processes and aligned with Science 37 systems and external regulatory requirements
• Provide interpretation, guidance, and training regarding qualification and validation requirements in GxP
• Apply Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.
• Participate in project teams and author (as applicable), review and approve computer validation related documentation including but not limited to: risk assessments, validation plan, user requirements, specifications, UAT, traceability matrix, testing (FAT, SAT, IQ,, OQ/PQ), data migration, qualification/validation protocols and reports.
• Participate/lead in the review of current and future SDLC/CSV policies and procedures.
• Support initiatives related to audit readiness, management of internal audits and regulatory inspections, and responding to findings in areas of responsibility
• Demonstrate strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements.
• Implement, and/or maintain process Quality control plans that are in accordance with product or process risk level, and ensures those plans are consistently followed.
• Support execution of strategic vision or plan by collaborating with cross functional teams to identify required Quality Engineering skills and competencies.
• Actively coach talent across the tech organization on quality principles
• Partner with training to prepare user documentation and training materials
Duties include but are not limited to:
• Assure quality systems are followed and integrated with business processes and aligned with Science 37 systems and external regulatory requirements
• Provide interpretation, guidance, and training regarding qualification and validation requirements in GxP
• Apply Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.
• Participate in project teams and author (as applicable), review and approve computer validation related documentation including but not limited to: risk assessments, validation plan, user requirements, specifications, UAT, traceability matrix, testing (FAT, SAT, IQ,, OQ/PQ), data migration, qualification/validation protocols and reports.
• Participate/lead in the review of current and future SDLC/CSV policies and procedures.
• Support initiatives related to audit readiness, management of internal audits and regulatory inspections, and responding to findings in areas of responsibility
• Demonstrate strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements.
• Implement, and/or maintain process Quality control plans that are in accordance with product or process risk level, and ensures those plans are consistently followed.
• Support execution of strategic vision or plan by collaborating with cross functional teams to identify required Quality Engineering skills and competencies.
• Actively coach talent across the tech organization on quality principles
• Partner with training to prepare user documentation and training materials
Employee perks, benefits
The position offers:
• Exiting career opportunity with a US-based global leader in virtual clinical trials
• Growing environment and interesting career prospects
• Unique opportunity to deliver clinical trials of the future: decentralized/virtual clinical trials
• Remote work and the possibility of working from a corporate office in the near future
• Strong international management and team support
• Start-Up work environment (establishing business in Europe)
• Top-notch equipment such as the latest MacBook and monitor
• Competitive compensation and benefits
• Exiting career opportunity with a US-based global leader in virtual clinical trials
• Growing environment and interesting career prospects
• Unique opportunity to deliver clinical trials of the future: decentralized/virtual clinical trials
• Remote work and the possibility of working from a corporate office in the near future
• Strong international management and team support
• Start-Up work environment (establishing business in Europe)
• Top-notch equipment such as the latest MacBook and monitor
• Competitive compensation and benefits
Information about the selection process
Please apply directly via our hiring portal: https://erecruiter0051.kandidatenportal.eu/Job/130014
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
University education (Master's degree)
Postgraduate (Doctorate)
Educational Specialization
IT software systems
Language skills
English - Upper intermediate (B2)
Other knowledge
Agile methodologies - Advanced
Experience in the position/sector
3-5
Number of years of experience
5
Personality requirements and skills
• Strong problem-solving and communication skills (both written and verbal)
• Strong teamwork and interpersonal skills
• Strong teamwork and interpersonal skills
Advertiser
Brief description of the company
Clinical trials consulting and analytics
ID: 3915106
Posting date: 24.8.2020
2020-08-24
location: Remote work Position: IT Consultant, IT Tester, Service Engineer, Software Engineer, Systems Engineer Company: LongTaal, s. r. o.
Basic salary component (gross): 2 000 EUR/month