Akorn AG is an FDA/EU-GMP certified manufacturer in the pharmaceutical sector (ophthalmics) and part of the US-American Akorn Group with headquarter in Lake Forest, Illinois. At the Hettlingen site, high-quality sterile products such as eye drops, ointments and gels are aseptically produced, filled and packaged for international markets.

Supervisor Transfer QC Raw Material (m/f) 100 %

For our laboratory in Winterthur we are looking for an initiative and committed personality with immediate effect or by appointment, who will be responsible for the following main tasks:

Duties and responsibilities:

  • Supervision of the QC transfer group and coordination of the transfer-/validation activities for raw materials
  • Creation and review of transfer-/validation protocols and reports according to internal and international guidelines (EP, USP, ICH…)
  • Responsible for troubleshooting concerning analytical deviations as well as deviations regarding the laboratory
  • Creation and review of SOPs, CAPAs and Changes
  • Creation and review of qualification and calibration documents for laboratory devices / laboratory systems
  • Presentation of the progress of the transfer-/validation activities in international meetings
Qualifications:
  • Completion of a university degree in chemistry with several years of professional experience
  • Well-founded GMP experience and good knowledge of instrumental analysis (HPLC, GC and Particle Size Distribution with Mastersizer 3000)
  • Profound knowledge in the validation of methods or in their transfer and verification according to USP and additionally in the qualification of laboratory equipment
  • Leadership experience is an advantage
  • Good spoken and written German & English knowledge
  • Good knowledge of IT (MS Office etc.)
  • Knowledge of the use of a CDS and a LIMS is an advantage
  • Knowledge of Lean Management for Laboratory Excellence programs is desirable

We offer you an interesting, varied and challenging job in a dynamic environment with a pleasant working atmosphere and attractive employment conditions.

Apply now!
akorn.ch