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Qualified Person (m/f/d)

  • University degree in natural sciences (e.g. pharmacy, chemistry, biology)
  • Required qualification as a Qualified Person according to § 15 AMG
  • Several years of professional experience in the industrial manufacture and testing of pharmaceuticals (quality control, quality assurance, production and / or development)
  • Excellent knowledge of drug laws and current national and international GMP regulations
  • Initial experience as an auditor desirable
  • Knowledge of SAP is of advantage
  • Performance of the tasks as a Qualified Person in accordance with § 14 AMG (German drug law) for the manufacture and testing of externally manufactured medicinal products
  • Batch certification for the marketing of medicinal products according to EU GMP guidelines, Annex 16
  • Coordination, organization and execution of Audits
  • Creation, review and negotiation of Technical Quality Agreements with contract manufacturing organizations and service providers
  • Qualification of suppliers and service providers
  • Processing, review and approval of Deviations, CAPAs, Complaints and Change Requests
  • Assessment of PQRs
  • Creation and review of SOPs and GMP / registration documents
  • Ensure compliance with the EU guidelines for Good Distribution Practice (GDP) and the requirements of the narcotics act
  • Coordination of product launches from QA perspective
  • Maintenance and further development of the Quality Management System
  • Participation in Customer audits and Authority inspections and follow-up of observations

» Job description

Acino AG
83714 Miesbach