Die Akorn AG ist ein FDA/EU-GMP zertifizierter Hersteller im Pharmabereich (Ophthalmika) und Teil der US-amerikanischen Akorn-Gruppe mit Sitz in Lake Forest, Illinois. Am Standort Hettlingen werden für internationale Märkte qualitativ hochstehende Sterilprodukte wie Augentropfen, -salben und -gele aseptisch produziert, abgefüllt und verpackt.
Manager Product transfer QC (m/f) 100 %

In this interesting position you will be responsible for leading 2 teams (API transfer and finished products) responsible for analytical transfer and validation activities. In addition, you will be responsible for planning analytical activities with the help of an analytical transfer specialist. You will report directly to the Executive Director Quality of the site. We are looking for an initiative and dedicated individual, starting immediately or by appointment, who will be responsible for the following main tasks:

Duties and responsibilities:

  • Personnel and technical leading of the Product transfer QC department
  • Planning of analytical method transfer activities
  • Ensure Transfer activities on time according to plan
  • Presentation of the progress of the transfer-/validation activities in international meetings
  • Coordination and control of activities like Changes and CAPAs
  • Creation and review of transfer-/validation protocols and reports according to internal and international guidelines (EP, USP, ICH…)
  • Control and coordinate troubleshooting activities concerning analytical deviations and OOS
  • Review of SOPs and methods
  • Review of qualification and calibration documents for laboratory devices / laboratory systems
  • Assist in Strategy product transfer planning activities global and local level
Qualifications:
  • Completion of a university degree in chemistry with several years of professional experience
  • Well-founded GMP experience and good knowledge of instrumental analysis (e.g. 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
  • Good spoken and written German & English knowledge
  • Good knowledge of IT (MS Office etc.)
  • Knowledge of the use of a CDS and Quality IT-systems
  • 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.

Wir freuen uns darauf, Sie kennenzulernen!
akorn.ch