Qualified Person To External Quality – Global Quality Operations
AstraZeneca
Södertälje, Sweden
Eu qualified person legal eligibility
Batch certification of external products
Gmp compliance and cgmp requirements
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 partnering with global functions like External Supply and Manufacturing.
The position requires upholding compliance for the EQ AstraZeneca AB MIA and API/Drug Substance registration License for products covering more than 45% of AZ VoP.
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
GMP compliance and cGMP requirements
External contract manufacturer oversight
MSc Pharmacy or equivalent degree
Five years pharmaceutical QA experience
Nice-to-have
Previous Qualified Person experience
Biologics and sterile manufacturing knowledge
Lean methodology application
Global supply chain collaboration
Conflict resolution and negotiation skills
Key Requirements
Formal QP qualification under EU Directive 2001/83/EC
MSc Pharmacy degree with specific chemistry and biology courses
Minimum five years experience in drug manufacturing and QA
Fluency in Swedish and English languages
Assessment by Swedish Medicinal Products Agency
Work Rights
Must have legal eligibility to act as QP in Sweden