Beschreibung
Job Purpose:Complex projects or late phase projects in the area of Digital therapeutic solutions, Manage global initiatives; Manage complex projects (cross sites, high impact); Due diligence independently. Manage processes to support departmental digital portfolio, projects and objectives according to agreed timelines and standards. Ensure that compliance with cGMP is maintained in TRD.
Major Accountabilities:
- Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise in the area of Digital therapeutic solutions to Line Unit and other QA Units in area of responsibility.
- Write, review, decide on approval and/or release of GMP-relevant deliverables and or/ related tools as per area of responsibility in order to ensure com-pliance with cGMP and project quality deliverables.
- Manage project related activities (e.g. TRD 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) as per area of responsibiity.
-- Support Project management functions as a project team member.
- Provide support to TRD line functions in GMP related topics as per area of re-sponsibility.
- Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).
- Delegation/ deputizes for Peers with same area of responsibility or senior quality manager
Ideal Background:
- Education (minimum/desirable): Graduate Masters, PhD, Bachelor/ Technician (? 5 years’ in Software as Medical Device)
- Languages: Fluent English required (oral & written). Good skills in site (local) language desired (oral).
Experience/Professional requirement:
• 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.