Qualified Person (QP)

Your tasks ...

• Direct contact person for contract manufacturers in all relevant quality issues (CMO management)
• Preparation, review and approval of GMP-relevant documents in the area of responsibility (testing and manufacturing instructions/documentation) and ensuring that these comply with the approvals and the relevant EU-GMP guidelines)
• Performance of the function as a Qualified Person (QP) / batch certification and batch release of the medicinal products manufactured on order and those imported from non-EU countries in accordance with the legal requirements (AMG, AMWHV, EU-GMP Guideline)
• Active networking through targeted establishment of relationships with international stakeholders, participation in their qualification and monitoring
• Maintenance of regulatory documents, contact person for regulatory-pharmaceutical issues
• Preparation, evaluation and approval of Product Quality Reviews
• Approval / release of suppliers / manufacturers
• Preparation and accompaniment of supplier audits and inspections by authorities

We offer ...

• Flexible working hours
• A good payment
• Your cooperation in a young, dynamic, modern, internationally operating company
• Your own area of responsibility
• Interesting, varied and challenging tasks in a motivating working environment with high national and international quality standards
• Promotion of your personal and professional qualifications through needs-based training and further education
• Company canteen
• Possibility to work from home on a pro rata basis

We look forward to receiving your application, please only via e-mail!

AMETAS medical GmbH

Christophstraße 6-8 | 09212 Limbach-Oberfrohna

Oliver Förste and Susann Frei, Managing Directors

Tel.. 03722 4696288 | info@ametas-medical.de