AstraZeneca
Biopharmaceutical
SeniorQualitySpecialistExternalQualityResponsiblePerson(Budapest)
“Senior Quality Specialist External Quality - Responsible Person (Budapest) at AstraZeneca. Skills: External Quality, Responsible Person, GDP compliance. Review incoming medicinal products. Assess incoming documentation”
What You'll Achieve.
Safeguard product quality; Enable safe release of medicinal products
Industry & Context.
Deviation investigation; Corrective actions
What They're Looking For.
Must Have
Degree in Pharmacy, 1 year experience as Responsible Person, Understanding of GDP requirements, Experience in pharmaceutical quality systems, Fluent English, Valid driving licence
Nice to Have
1–5 years experience in GDP environment, Experience in GMP
What You'll Do.
Review incoming medicinal products
Assess incoming documentation
Certify incoming products
Release products for sale
Block products where necessary
Be present onsite during receipt
Oversee goods receipt
Oversee organoleptic inspection
Ensure segregation of damaged goods
Monitor compliance with procedures
Ensure adherence to storage conditions
Ensure adherence to transportation conditions
Oversee ambient products
Oversee temperature-controlled products
Manage product complaints
Manage quality defect reporting
Support product recalls
Investigate deviations
Implement corrective actions
Conduct self-inspections
Conduct internal audits
Participate in external audits
Participate in third-party audits
Deliver training to internal QA staff
Deliver training to warehouse personnel
Deliver training to logistics personnel
Maintain collaboration with Regulatory Affairs
Maintain collaboration with Logistics teams
Maintain collaboration with Finance teams
Maintain collaboration with Marketing
Maintain collaboration with Business Units
Maintain collaboration with Regional partners
Maintain collaboration with Wholesalers
Maintain collaboration with external partners
Ensure compliance with Hungarian legislation
Ensure compliance with EU legislation
Ensure compliance with GDP requirements
Ensure compliance with GMP requirements
Ensure compliance with EFPIA Codes
Ensure compliance with AIFP Codes
Support pharmacovigilance obligations
Report safety information
How You'll Work.
Team & Collaboration
Internal teams; Regional stakeholders; Regulatory bodies; Regulatory Affairs; Logistics teams; Finance teams; Marketing teams; Business Units; Regional regulatory partners; Regional logistics partners; Wholesalers; External partners; Regulatory authorities
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