Senior Quality Assurance Associate

Vor 3 Tagen


Solothurn, Solothurn, Schweiz Biogen International GmbH Vollzeit

About This Opportunity



We're looking for a Senior Associate I within the Integrated Upstream Quality Operations team to play a pivotal role in the Quality Department of our cutting-edge Large-Scale Manufacturing facility in Solothurn, Switzerland.



Your Focus



You will oversee shopfloor manufacturing operations, handle minor and major deviations, review quality documents, participate in validation and cleaning protocols, and engage in quality on-call duties.



Key Responsibilities




  • Electronic Batch Record and eLogbook review.
  • Minor and major deviations handling.
  • Change control and maintenance records review.
  • Validation and cleaning protocols participation.
  • Continuous improvement project leadership.
  • Subject matter expert in internal and external audits.
  • Quality on-call duty rotation.
  • Bulk drug substance batch review and record release facilitation.
  • Continuous improvement ideas implementation.
  • Cross-functional team collaboration.
  • GMP CAPEX and OPEX project expertise.


Requirements



To succeed in this role, you'll need:




  • Bachelor's degree in Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, or Pharmaceutical Regulations.
  • Minimum 8 years of experience in a GMP pharmaceutical or biotech manufacturing environment.
  • At least 3 years of experience in a Quality Assurance role.
  • Strong presentation and organizational skills.
  • English proficiency at a B2 level minimum.


PREFERRED SKILLS




  • Quality assurance and quality engineering experience in upstream processes.
  • Skills in collaboration and coaching.


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