Our client is a leader within the Pharmaceutical Industry. On behalf of our client, Swisslinx is currently looking for a Quality Manager - Digital applications, to join a 6 month contract with a possible extension in Basel area.
- 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, and decide on approval and/or release of GMP-relevant deliverables and or/ related tools as per area of responsibility in order to ensure compliance 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 responsibility
- Support Project management functions as a project team member
- Provide support to TRD line functions in GMP related topics as per area of responsibility
- Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).
- Experience in writing, reviewing and approving 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
- Experience in ensuring 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
- Experience in improving the overall quality of mobile software, including peer reviews, software hazard analysis, requirements traceability, defect tracking, software metrics, configuration management and software tool validations
- Experience in ensuring 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