In a few words
Position: Global Quality Assurance Specialist
Location: Spain (reporting to Turkey)
Experience: 2-5 years in Quality Management Systems within pharmaceutical/biotech industry
Want to know more?
At Insud Pharma, we operate across the entire pharmaceutical value chain, committed to innovation and sustainable development. Our Global Quality Management unit drives excellence worldwide, ensuring regulatory compliance and continuous improvement to safeguard human and animal health.
Are you ready to be a #Challenger and make a real impact in the pharmaceutical industry? Join us!
What are we looking for?
- Support the implementation, maintenance, and continuous improvement of the global Quality Management System (QMS).
- Participate in defining and executing the global QMS strategy aligned with FDA, EMA, and other international regulations.
- Assist in harmonizing and standardizing key processes: CAPA, deviations, change control, audits, training, supplier management, and product release.
- Prepare and support regulatory inspections and internal/external audits.
- Manage digital QMS tools (TrackWise, LIMS), ensuring compliance with 21 CFR Part 11 and EudraLex Annex 11.
- Monitor key performance indicators (KPIs) and prepare periodic reports to assess system effectiveness.
- Implement risk management principles across quality processes.
- Support the integral audit program and supplier qualification.
- Promote a strong quality culture and continuous training throughout the organization.
The challenge!