Qualified Person To External Quality – Global Quality Operations
AstraZeneca
Södertälje, Sweden
Eu qualified person legal eligibility
Batch certification of external products
Cgmp compliance assurance
The role involves acting as a formal Qualified Person on the AstraZeneca AB MIA to ensure all certified batches comply with registered CMC dossiers and GMP standards
Job Summary
The role involves acting as a formal Qualified Person on the AstraZeneca AB MIA to ensure all certified batches comply with registered CMC dossiers and GMP standards.
You will serve as the Regional Process Champion for Batch Review, Release, and Certification while driving continuous improvements within the global supply chain.
This position requires strong leadership to partner with diverse global functions and influence a network of external suppliers across the EU and third countries.
Matching Summary
The role involves acting as a formal Qualified Person on the AstraZeneca AB MIA to ensure all certified batches comply with registered CMC dossiers and GMP standards.
Skills & Requirements
Must-have
EU Qualified Person legal eligibility
Batch certification of external products
cGMP compliance assurance
External contract manufacturer oversight
Swedish and English fluency
Nice-to-have
Lean methodology experience
Biologics manufacturing background
Sterile and OSD packaging knowledge
Conflict resolution and negotiation skills
Global supply chain partnership
Key Requirements
MSc Pharmacy or equivalent degree with specific chemistry/biology courses
Minimum five years' experience in pharma manufacturing and QA
Formal QP qualification under EU Directive 2001/83/EC
Eligibility to act as QP on Swedish MIA license
Fluency in Swedish and English languages
Work Rights
Must be eligible to act as QP on Swedish MIA license