22.10.2025 aktualisiert
100 % verfügbar
Head Ouality Unit, Qualified Person AMG 15.3/3a, Director Site Quality, Director Quality Assurance
Buchloe, Deutschland
Weltweit
Dr. rer. nat., Diplom-ChemikerSkills
APIsAsepsisAuditsMolekularbiologieBiopharmazeutikaDue DiligenceImmunisierungIso 13485SachgüterproduktionMikrobiologiePharmazieQualitätsmanagementTablettenQualitätskontrolleQualitätsstrategie
Aseptic Manufacturing (fill / finish, syringes, vials), ATMPs, vaccines, APIs (large and small molecules), lyophilsation, combination products (autoinjectors), tablets, capsules, ointments, creams, suppositories, ovules, radionucleids,
Qualified Person, AMG §15.3 & 3a, Leiter der Herstellung, Leiter der Qualitätskontrolle
Quality Assurance, Quality Control (including bioanalytics and microbiology), Site Quality Head
Auditing, Due Diligence, Inspection Management
Internaltional experience (US, EU, Japan, South Korea, India, China)
EU GMP (Part 1 -4, all annexes), 21CFR211, 600ff& 820, ISO 13485, MDR
Qualified Person, AMG §15.3 & 3a, Leiter der Herstellung, Leiter der Qualitätskontrolle
Quality Assurance, Quality Control (including bioanalytics and microbiology), Site Quality Head
Auditing, Due Diligence, Inspection Management
Internaltional experience (US, EU, Japan, South Korea, India, China)
EU GMP (Part 1 -4, all annexes), 21CFR211, 600ff& 820, ISO 13485, MDR
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Audits in the EU and China,
Audit at contract labs and contract manufacturers, API & excipient suppliers
Audit at contract labs and contract manufacturers, API & excipient suppliers