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
- 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 firstname.lastname@example.org.