Beschreibung
Our client global medical devices company is looking for An experienced quality assurance expert for a temporary role to manage projects in the area of Digital therapeutic solutions according to agreed timelines and GMP standards.Major Accountabilities:
1. provide functional expertise in Digital therapeutic solutions to the QA Department for assigned projects
2. Write, review and release of GMP-relevant reports in order to ensure the compliance with cGMP and project quality deliverables.
3. Manage project related activities (digital product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects)
4. Support Project management functions as a project team member.
5. Provide support to the line functions in GMP related topics
6. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).
Ideal Background:
Graduate Masters, PhD, Bachelor/ Technician
* Write, Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance.
* Ensure that new products including web-based and mobile applications have been effectively and efficiently verified and validated prior to their release and that these designs meet effectively documented and implied user needs and requirements.
* Improve the overall quality of mobile software, including peer reviews, software hazard analysis, requirements traceability, defect tracking, software metrics, configuration management and software tool validations.
* Ensure that software quality assurance efforts are lifecycle oriented during product requirements development and continuing throughout its lifetime.
Practical experience in ISO 13485, IEC 62304, IEC 82304, ISO 14971, MDD/MDR, GDPR, 21 CFR part 820 / part 4 requirements and in Medical Mobile Applications.
Please send your CV in application
Michael Bailey International is acting as an Employment Business in relation to this vacancy.