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01.07.2010Quality Assurance Manager / GxP-Auditor (m/f)

 

The company AiCuris is specialised in infectious diseases. The company's activities comprise discovery, research and development of novel antiviral and antibacterial agents in the indications HIV, Herpes, Hepatitis B and C, Human Cytomegalovirus and (multi)resistant bacterial infections treated in the hospital. The highly innovative pipeline of AiCuris addresses specialist markets and severe, potentially life threatening infections with high medical need.

Currently AiCuris is offering a position as

Quality Assurance Manager / GxP-Auditor (m/f)


He/she will report to the CEO and

  • conducts internal and external system audits as well as trial-related audits (phase I -III) in accordance with SOPs- GCP- applicable law and guidelines
  • plans, organizes, and document all audits and follow-ups
  • organizes and attends sponsor inspections by authorities (local and international)
  • controls corrective and preventive actions (CAPA)
  • designs, maintains and develops further the company's SOP system
  • plans, organizes and documents SOP and GxP-trainings
  • works together with all functions and departments in-house relating to quality issues
    Skills and Qualifications
  • academic degree in science, pharmacy or medicine
  • at least 3 years of experience with quality management in the pharmaceutical industry as well as local and international audit conduction 
  • very good knowledge of GxP regulations in Germany, Europe and US
  • excellent, proven interpersonal and communication skills ability to proactively participate in a team with diverse personalities 
  • flexibility and willingness to travel
  • fluent written and spoken English and German skills
  • excellent knowledge of Microsoft Office applications

We offer an exciting and challenging job in an expanding and innovative company with an excellent R&D portfolio and a highly motivated team exhibiting many years of Big Pharma experience.

How to apply

To apply, please submit your full application inclusive your curriculum vitae and salary require¬ments exclusively via email at jobs@aicuris.com.

Contact

AiCuris GmbH & Co. KG, Mrs Sandra Wildhagen, Friedrich-Ebert-Str. 475/Building 302, 42117 Wuppertal


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