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QA Review Manager (f/m/d)

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.  
Bachem. Leading Partner in Tides 

In order to continue our organic growth, we are constantly looking for talent.

Your responsibilities 


We are looking for a well-organized and highly motivated QA Review Manager for strengthening our QA project management team within our QA/RA department. Our group is responsible to support NCE-, generic- and company projects regarding all quality related topics. In the important role of the QA Review Manager you are responsible to autonomously review and approve manufacturing instructions, analytical instructions for in-process-controls and the related change controls in our electronic quality management system. A related task for you is the customer notification and approval of these documents. In addition, you are responsible the review and approval of technical reports and risk assessments. Due to the variety of our projects you will collaborate with different production units, QA and various customers. You are a team player that cooperatively provides guidance on GMP related topics and enforces the inter-divisional project team in QA-related decisions by powerful arguments you effectively support the projects throughout the whole project life cycle.

 

Ihr Profil

  • You have a Master degree or Ph.D. in Chemistry or Pharmacy or an equivalent qualification 
  • At least two years of experience in the chemical/pharmaceutical industry with a focus on the compilation or review of manufacturing and/or analytical documents 
  • Very good cGMP knowledge including sound knowledge of international and national cGMP- requirements and other quality assurance guidelines
  • You work service minded, task-oriented, detail-oriented, structured, with excellent organizational skills
  • Excellent time management skills and a multi-tasking ability will enable you to effectively manage multiple, complex priorities
  • You have excellent communication skills including verbal and written communication skills and an excellent command of English and German 
  • Experience with electronic systems like Mastercontrol is a plus

 

We offer 
We offer an exciting and challenging job in a dynamic and growing environment which guarantees diversity and personal advancement. 

 

Interested
If this information draws your attention and you enjoy working and communicating with peptide experts across all disciplines, we look forward to receiving your complete dossier. 
Please submit your application with full supporting documents (motivation letter, CV, testimonials, diplomas) online to Mrs Fabienne Carabelli.