Head of Quality Assurance

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Head of Quality Assurance

Our client is a biopharmaceutical CDMO specialising in the development and production of clinical trial materials, primarily for phases I + II. Technology includes aseptic processing for live viruses and bacteria starting with process development, drug substance, and drug product manufacturing (fill & finish).

Aseptic manufacturing processes and the fill & finish capabilities, in particular, are considered by our clients as a unique selling proposition.

They are serving the indications Oncotherapy/Virotherapy, Gene Therapy and development of
new vaccines.  

Responsibilities

  • Improvement and Maintenance of the Quality System
  • Responsible for audits of customers and authorities
  • Management of documents incl. SOPs, manufacturing- and testing instructions, stability plans
  • Monitoring of rooms, utility service and equipment (Life cycle management) with respect to
  • GMP compliance
  • Management of QPI (Quality performance indicators): deviations, changes, CAPA, OOS
  • Release of qualified rooms, utility service and equipment for GMP production
  • Release of validated processes for (aseptic) production
  • Release of validated test methods for release testing
  • Performance of self-inspections and audits of contractual testing laboratories and suppliers
  • Contact person for authorities
  • Monitoring of GMP-knowledge of staff

 

Qualifications and Experience

  • 5 years of QA experience with increasing responsibility
  • Good communication skills
  • Good management skills
  • Fluent in German at least, native speaker not required.  

 

For more information or, if you’d like to be considered for this position, please call us on +44 20 3637 4393 or email enquiries@gxpeople.com.


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Quality is not an act. It is a habit
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