09 sep
|
Insud Pharma
|
Comunidad de Madrid
09 sep
Insud Pharma
Comunidad de Madrid
In a few words ?
Position: QA Coordinator Germany
Location: Ismaning, Germany
Work model: Hybrid
Experience: 2–3 years of relevant experience, including at least 2 years in Quality Assurance or Quality Systems
Want to know more? ?
Exeltis is an international pharmaceutical company focused on the development and commercialization of high-quality healthcare solutions. The company operates in a regulated environment with a strong commitment to compliance, quality standards, and continuous improvement across all relevant markets and business activities.
We are currently seeking a QA Coordinator Germany to support Quality activities across affiliates/subsidiaries within scope and to contribute to the implementation and maintenance of effective Quality Systems in line with applicable regulatory and internal requirements.
What are we looking for? ?
The position is responsible for supporting compliance with GxP, regulatory, and internal Quality standards within affiliates/subsidiaries, with a particular focus on documentation management, technical quality agreements,
third-party oversight, quality metrics, and support to local Quality teams.
The challenge ?
- Ensure that suitable Quality Systems are established, implemented, and maintained in the markets within scope.
- Provide oversight to support compliance with local regulatory requirements and internal Quality policies.
- Manage Quality documentation, including procedures, reports, and related documents.
- Support regional and local Quality teams in the handling of significant Quality issues and Quality management documentation.
- Support the implementation of Quality training activities for affiliates/subsidiaries.
- Manage Quality Technical Agreements between third parties and Exeltis.
- Maintain appropriate oversight of third-party Quality activities in routine operations.
- Identify Quality-related risks and support the definition of mitigation measures.
- Develop and monitor Quality metrics for third-part
📌 Quality Assurance Coordinator (Comunidad de Madrid)
🏢 Insud Pharma
📍 Comunidad de Madrid