Manager m/w/d QA GMP TZ 80% Gehalt ab ca. 4800,00€ – 6.200,00€ pro Monat

Für unseren renommierten Kunden aus der Pharmaindustrie in Biberach suchen wir ab sofort:

Manager m/w/d QA GMP TZ 80% Gehalt ab ca. 4800,00€ – 6.200,00€ pro Monat

Ihre Aufgaben

  • Preparing and managing of passive audits and inspections in Development Germany i.e. Health Authority Inspections, Client Audits and Corporate Audits.
  • Monitors and manages follow-ups on defined action items, observations and CAPAs
  • Elaborates the risk assessments (risk based approach) for internal Quality Audits for Development Germany. Prepares and executes internal Quality Audits
  • Supports the Pre Approval Inspection (PAI), Preparation Team Lead (PPTL) for PAIs in Development, Biopharmaceuticals or Launch Site. Prepares the PAI and support Mock PAI execution by Boehringer Ingelheim Corporate as well as the actual execution of the PAI by the American Health Authorities (FDA). Coordinates any PAI related activities between the Launch Site and Development Germany

Ihre Qualifikationen

  • Master´s degree in natural sciences or similar disciplines or several years of relevant experience
  • Profound knowledge of cGMPs, related GMP processes and systems and their application for IMPs
  • Experience with Quality Systems and Quality Management within pharmaceutical industry
  • Experience with hosting / conducting audits & inspections
  • Profound knowledge of international regulatory guidelines and quality standards
    applicable to Human Medicinal Products
  • Experience in a GMP regulated environment (Pharmaceutical Development, Production, Quality Control, Quality Assurance). Hands-on experiences in either analytical testing, manufacturing, release of medicinal products or medical devices/combination products
  • Works efficiently and diligently, high sense of responsibility as well as independently, agile and be a team player
  • Fluent German and English


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Telefonnummer: +49 (73 51) 82 98 63 20

apero GmbH
Marktplatz 1
88400 Biberach an der Riß