QA Specialist

What are your responsibilities?

  • Manage and own NC records for External Quality 
  • Manage and own CAPA records for External Quality 
  • Manage and own Change Control records internal to External Quality 
  • Manage and drive Quality records to closure independently 
  • Perform tactical batch disposition activities in support of lot release 
  • Provide tactical information to the networks (i.e., metrics to management, data 
  • analysis, trending, periodic monitoring, APR) 
  • Escalate risks or roadblocks to management 
  • Drive timely decision making using local decision making principles 
  • Drive continuous improvements 
  • Demonstrate ownership for required training on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable) 
  • Engage &/or participate with ongoing improvement initiatives within the Regional work cell and the wider organisation 
  • Align and support the tools in use to manage Regional Work Cell activities including Visual management, level loading, capacity & capability management 
  • Create and foster an environment of change and development within the Regional Work Cell and seek to influence beyond. 
  • Create and foster key relationships to enable timely completion of activities and responsibilities. 

Who are we looking for?

  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry 
  • Bachelor’s Degree in a Science Field 
  • GMP Experience 
  • Ability to oversee multiple projects simultaneously 
  • Able to successfully manage workload to timelines 
  • Ability to negotiate a position after taking feedback from multiple sources 
  • Demonstrated ability to consistently deliver on-time, and high-quality results 
  • Ability to operate in a matrixed or team environment 
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) 
  • Ability to travel +/- 10% of time to domestic and international sites

What does QbD offer you?

  • A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
  • Real investment in people through education and fun events
  • A competence development model focused on your personal ambitions
  • An attractive salary package

Interested? Apply now by sending us your CV and motivation.