Quality Systems Specialist (m/f/d)

The Manager Quality Systems (m/f/d) maintains all processes related with the Global Quality System in order to ensure compliance with all GxP Guidelines. The Quality System should also be perfectly adjusted with the business model and correct commercial activities supporting purchase, release and distribution of medicinal products, active ingredients and medical devices for our Business Unit Pharma.

Your tasks:

• You will maintain and continually update the Global Document System to ensure it aligns with all EU operating authorizations and licenses.
• Your role will ensure compliance with GxP guidelines, including GMP, GDP, GCP, and GLP standards.
• You will implement and oversee external document and process change control procedures to ensure seamless integration of updates.
• Managing the qualification process for suppliers and customers, including ongoing performance assessments with a focus on quality standards, will be part of your responsibilities.
• Overseeing the audit process, including planning, execution, and support, to ensure all audits are completed effectively and within set timelines will be essential.
• You will maintain and enhance the CAPA (Corrective and Preventive Actions) system to address quality issues and prevent recurrence.
• Conducting audits of contracting companies, suppliers, and service providers worldwide, ensuring compliance with GMP and GDP regulations, will be required (experience is preferred but not mandatory).
• Managing and maintaining the quality training system to ensure training programs meet identified needs and GxP requirements and implementing and monitoring department-specific quality metrics (KPIs) to drive continuous improvement, will also be key tasks of this role.

Your profile:

• You hold a degree in Pharmacy, Life Sciences, Chemistry, or a related field, with relevant experience in quality management systems.
• In addition, you demonstrate a solid understanding of GxP guidelines, including GMP, GDP, GCP, and GLP, to ensure compliance with regulatory standards.
• Moreover, you have proven ability to maintain and continually update a Global Document System in alignment with EU operating authorizations and licenses.
• You are also confident in implementing and managing external document and process change control procedures to ensure seamless integration of changes.
• Furthermore, you oversee the qualification process of suppliers and customers, including ongoing performance assessments with a focus on quality standards.
• You manage audits effectively, including planning, execution, and support, ensuring they are completed within set timelines.
• The CAPA system will also be regularly maintained and enhanced to address quality issues and prevent recurrence.
• Lastly, you handle the quality training system, ensuring training programs meet GxP requirements and department-specific needs.
• Fluent English language skills are essential and you are also familiar with common IT applications (MS Office 365).