Dipl.-Ing. Marcus Basan

Single point of contact for external and internal partners Ensures that the operational business is in compliance with cGMP, QA Agreements, regulatory and internal requirements Responsible for Supplier Qualification, Quality Agreements, coordinating and for ensuring that Quality auditing of External suppliers is carried out and action plans are in place and implemented Provide strategic and tactical support for the Supplier Relationship Team in driving Supplier Development, Savings and other initiatives.

Responsible for timeliness and completeness of Quality Escalations and Risk Assessments (Investigations and effectiveness of CAPAs according cGMP and internal procedures. Single point of contact for external partner [CMO's] and internal stakeholders in terms of quality related issues (QAA, Change Control; PQR etc.) Provide strategic and tactical support for the Supplier Relationship Team in driving Supplier Development, Savings and other initiatives.

Responsible for timeliness and completeness of complaint and deviation investigations and effectiveness of CAPAs according cGMP . Single point of contact for external partner [CMO's] and internal stakeholders in terms of quality related issues. Support of Qualified Person during Certification Process of medicinal prducts. Provide strategic and tactical support for the Supplier Relationship Team in driving Supplier Development, Savings and other initiatives.

Deputy Head of 16 lab technicians in the function as "Leiter Qualitätskontrolle" according to German "AMWHV - $14" Implementation of lean management processes on laboratory level.

Quality Assurance Manager - Qualification and Validation of technical Equipment for production of medicinal products [Semi-Solids]

Qualitätssicherung, Mikrobiologie, Biotechnologie, Arzneiformenlehre