Qualification monitoring and management of critical business partners/service providers (e.g. TPIs) for FME D GmbH to ensure regulatory compliance of distribution channels to the end consumer based on valid processes and regulatory requirements within the respective area of responsibility
QAA control (timely creation completion and maintenance based on centrally provided templates)
Support with Initiation of mapping measures for the qualification and support of distributors pharmaceutical wholesalers and critical service providers
Collaboration with the drafting updating and maintaining quality assurance agreements with distributors wholesalers and critical service providers in close cooperation with Q & R Hub
Provide oversight over QAA status with TPIs/FME subsidiaries and respective reporting to relevant stakeholders
Interface management for operational questions to the QAA with for example DGRA Labelling Office GTO TPI Governance Medical Device Vigilance and Trading Goods Department regarding their impact on TPI QAAs
Preparation and support in internal and external surveillance audits
Support with preparation of other service level or service agreements
Implementation of quality assurance mapping measures
Collaboration in international and cross-departmental project work
After obtaining the appropriate auditor qualification conducting audits of critical service providers (e.g. distributors FME marketing & sales organizations within the framework of the quality management system or audits with a changed or extended scope such as ISO 13485 GDP etc.)
The position holder will take on project tasks in the area of Regulatory Affairs & QMS International that are initiated to ensure compliance with external requirements as well as to support the identification definition implementation monitoring reporting and follow-up of corporate processes and directives
Required Experience:
Senior IC
Senior Specialist- Distributor Management • Bengaluru, Karnataka, India
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