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.