Senior Quality Service Specialist
- Implementation and management
of an internal quality management system according to ISO and cGxP regulations
(ISO9001:2015, ISO13485:2016, ICHQ10, GMP, GDP, WDA) in accordance with EU
(laws of applicable countries) and FDA requirements
- Responsible for Authority
Communication and Audit Management and readiness programs
(Regierungspraesidium, notified bodies)
- Management of the focus areas
QMS, Quality Assurance, Regulatory, CSV, Quality Systems, Medical Devices and
Quality Services
- Documentation officer and
responsible for maintaining internal ISO and GxP standards
- Co-development and process
setup of QMS, GMP and GDP software solutions in accordance with EU GMP Annex
11, CRF 21 Part 11
- Creation and processing of
validation documents (CSV) in accordance with GAMP5
- Implementation of an eDMS and eLMS
and associated process development with stakeholders
- Collaboration for the creation
of electronic learning courses (Pharmuni)
- Medical Device Technical
Documentation according ISO13485, MDR and IVDR
- Monitoring data integrity
during process development
- Deviation, investigation,
CAPA, change control and complaint management.
- Supplier management in
accordance with cGMP and cGDP requirements
- Conducting compliance checks,
gap and risk analyses of data, documents, processes, regulations and standards
- Implementation and management
of system risk and GxP assessments