Head of Quality Assurance

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Head of Quality Assurance

 

GxPeople is currently working with a global client who is seeking a Head of Quality Assurance to join their team in Germany.

Responsibilities

  • Professional and disciplinary leadership of a team of 3 employees
  • Ensuring and adherence to GMP guidelines
  • Batch record review and approval of critical raw materials
  • Creation, testing and approval of quality-relevant documents (eg SOPs, work and production instructions, plans and reports )
  • Monitoring and processing of change control, variance and OOS procedures and processing of the associated trendings
  • Creation and evaluation of Product Quality Reviews / Annual Product Reviews
  • Conducting supplier audits, participation in official inspections and customer audits


Qualifications and Experience

  • Successfully completed scientific studies and several years of professional experience in quality assurance, ideally in the bio pharmaceutical industry
  • Very good knowledge of the relevant regulations (eg EC GMP, ICH, FDA)
  • Practical experience in the GMP environment
  • Ideally good knowledge in biotechnological production as well as Protein analysis and microbiology
  • Resilience, assertiveness and a good technical understanding
  • A very careful and precise way of working distinguishes you
  • You have an eye for the essentials and the overall context
  • Very good English and MS Office skills


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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