EN
EnsoDataQuality Assurance Engineer
QA Engineer developing E2E automation framework for web and mobile applications in healthcare. Ensuring quality and regulatory compliance in a hybrid work environment.
About the role
- Prepare, conduct and follow up on all types of internal and external GxP/GCP audits
- Provide leadership and support in clinical audit activities for internal and external parties (service providers, clinical sites)
- Work with Business Leads to ensure resolution of audit findings/non-compliant issues and approve CAPA plans
- Conduct peer review of audit reports and support operational staff preparing for customer audits
- Host client and regulatory inspections and manage inspection readiness
- Prepare investigational sites and guide staff in developing inspection readiness strategies
- Act as subject matter expert for inspectors and train backroom support teams
- Manage teams during inspections and host regulatory inspections for clients as required
- Facilitate generation and revision of Controlled Documents (Policies, SOPs)
- Support and guide completion of risk assessments and root cause analyses for Quality Issues
- Assist in preparing robust CAPA plans and track them through to completion
- Drive continuous improvement and development of routines to increase quality and compliance
- Assist with business development of external quality and compliance services and attend client meetings
- Provide quality advice and support to internal and external clients
- Lead clinical non-compliance investigations and CAPA implementation; identify systemic gaps and escalate critical issues as appropriate
Requirements
- University/college degree in a scientific area (for Italy: Life Science degree required)
- Awareness of the clinical trial area in CRO and/pharma industry
- Knowledge of GCP/GxP regulations and standards (e.g., ICH E6 GCP)
- Deep understanding of GCP/GxP regulations to interpret audit findings
- At least five (5) years’ experience in clinical trials, including quality assurance and quality operations
- CSV knowledge and experience are a plus
- Adheres to ethical and good clinical practices
- Ability to work as part of a team and independently in a remote workforce environment
- Excellent interpersonal and communication skills
- Ability to work on multiple projects with competitive timelines
- Highly analytical with strong attention to detail
- Pro-active, anticipates issues and develops solutions
- Good planning, organisation and problem-solving abilities
- Demonstrated ability to multitask, prioritize, and complete objectives
- Excellent oral and written communication skills
- Fluent in English, both written and verbal
- Advanced user of MS Office applications (Outlook, Word, Excel, PowerPoint)
- For candidates based in Italy: compliance with the Italian MoH Decree dated 15th November 2011 (G.U. n°11 dated 14th January 2012)
Benefits
- Competitive compensation package
- Comprehensive benefits
- Opportunity for personal and professional growth
- Fully remote / home-based work options
- Hybrid work options in select locations (Warsaw, Lund)
- Collaborative, innovative team environment
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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