Head of Quality Control (m/f)

Einsatzort: Ludwigshafen

Head of Quality Control (m/f)

Head of Quality Control (m/f)

Job purpose:

  • Assurance of analytical testing of drug products, intermediates, stability samples, raw materials, packaging materials, delivered to or manufactured in Ludwigshafen. Assurance of environmental monitoring for all operations manufacturing facilities as well as parenteral pilot plants.
  • Analytical results are the basis for final release and batch disposition with respect to:
    • Regulatory and legal requirements (AMG, AMWHV, GMP)
    • Company processes and procedures
    • Regulatory submissions
    • Best scientific and technical practice (ICH, PhEur,USP, BP)

Your responsibilites:

  • Head Quality Control (German Drug Act, AMWHV §12 / §14)
  • Evaluation, verification and release of analytical results for drug products, intermediates, stability samples, raw materials, packaging materials as Head of Quality Control according to the German drug act
  • Assurance and Maintenance of GMP status within GPQC labs including internal and external audits and inspections
  • Assurance of complete, correct and timely testing of drug products, intermediates, stability samples, raw materials, packaging materials and environmental monitoring samples
  • Assurance of the internal and external environmental health and safety requirements
  • Handling of laboratory events / exceptions like OOS, OOT
  • Support of analytical method transfer, method optimizations and validation
  • Budget Planning and administration
  • Process optimization and standardization of work flows within GPQC
  • Support of Product quality reviews
  • Measurement of Key Performance Indicators
  • Representation of GPQC internally and externally
  • Coordination and communication with Third Party Labs, Third Party Manufacturer and Customers with respect to analytical testing
  • Leadership of 90- 100 subordinates with respect to Training, Feedback, Motivation and personel Development
  • System Owner for QC related IT systems (LIMS,CDS, stand-alone instrument software)
  • System Owner for all analytical instruments in QC Labs

 

  • University/FH degree in sciences like chemistry, biology, pharmaceutical sciences or equivalent degree or equivalent experience
  • Approbation as licensed pharmacist preferred
  • Experience and Knowledge in Regulatory and legal requirements 2-5 years
  • Experience and Knowledge in analytical sciences / pharmaceutical analytical sciences 2-5 years
  • Leadership experience 2-5 years
  • Experience and knowledge in handling of laboratory events and exceptions
  • Experience in evaluation of analytical results and analytical test methods
  • Experience in collaboration with internal / external and national / international colleagues
  • Fluent in English

We are looking forward to your application. Please provide information about your salary expectations and possible start date in your motivation letter.
 
An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.
 
Learn more about AbbVie Deutschland at www.abbvie.de. Visit www.abbvie-care.de for more information about the therapeutic areas in which we’re active.

 

 

 

AbbVie (NYSE:ABBV) ist ein globales, forschendes BioPharma-Unternehmen, das sich der Entwicklung innovativer Therapien für einige der komplexesten und schwerwiegendsten Erkrankungen der Welt verschrieben hat. Mission des Unternehmens ist es, mit seiner Expertise, seinen engagierten Mitarbeitern und seinem Innovationsanspruch die Behandlungsmöglichkeiten in vier Therapiegebieten deutlich zu verbessern: Immunologie, Onkologie, Virologie und Neurowissenschaften. In mehr als 75 Ländern arbeiten AbbVie-Mitarbeiter jeden Tag daran, die Gesundheitsversorgung für Menschen auf der ganzen Welt voranzutreiben. In Deutschland ist AbbVie an seinem Hauptsitz in Wiesbaden und seinem Forschungs- und Produktionsstandort in Ludwigshafen vertreten. Insgesamt beschäftigt AbbVie Deutschland rund 2.600 Mitarbeiter. Mit rund 29.000 Mitarbeitern weltweit vertreibt AbbVie Medikamente in mehr als 170 Länder.

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