Senior Quality Specialist External Quality Responsible Person (Budapest)

Senior Quality Specialist External Quality - Responsible Person (Budapest)

Diverse Minds. Bold Disruptors. Meaningful Impact.

AstraZeneca is a global science-led patient-focused biopharmaceutical company that focuses on the discovery development and commercialization of prescription medicines for some of the worlds most serious diseases. But were more than one of the worlds leading pharmaceutical companies.

Its our patients that come first every decision we make and action we take is centered around how we can better respond to their evolving needs as well as those of healthcare professionals and partners. Its why we are shaping patient care for the future working along the whole experience to give hope to billions of lives across the world.

What youll do

We are seeking a qualified and experienced Senior Quality Specialist External Quality - Responsible Person to join AstraZenecas pharmaceutical wholesale operations in Hungary. This role is critical in ensuring compliance with GDP requirements safeguarding product quality and enabling the safe release of medicinal products to market.

The successful candidate will act as a key quality authority working closely with internal teams regional stakeholders and regulatory bodies.

Key Responsibilities

Quality Certification & Product Release

• Review assess and certify incoming medicinal products and associated documentation
• Release products for sale (placement into saleable stock) for domestic and regional markets
• Block products where necessary in case of quality concerns

Inbound & Warehouse Quality Oversight

• Be present onsite during receipt of medicinal product shipments
• Oversee goods receipt sampling and organoleptic inspection
• Ensure segregation of damaged goods
• Monitor compliance with approved procedures

Storage & Distribution Compliance

• Ensure adherence to storage and transportation conditions as defined in marketing authorisations
• Oversee both:
  • Ambient products
  • Temperature-controlled (cold chain) products

Quality Assurance Activities

• Manage product complaints and quality defect reporting
• Support product recalls (as Deputy Recall Administrator if assigned)
• Investigate deviations and implement corrective actions
• Review update and approve SOPs
• Conduct self-inspections and internal audits
• Participate in external and third-party audits (e.g. manufacturers logistics providers wholesalers)

Training

• Deliver training in line with the approved training plan to:
  • Internal QA staff
  • Warehouse and logistics personnel

Stakeholder Management

• Maintain close collaboration with:
  • Regulatory Affairs
  • Logistics and Finance teams
  • Marketing and Business Units
  • Regional regulatory and logistics partners
  • Wholesalers and external partners
  • Regulatory authorities

Regulatory & Compliance

• Ensure all activities comply with:
  • Hungarian and EU legislation
  • GDP/GMP requirements
  • EFPIA and AIFP Codes of Practice

• Support pharmacovigilance obligations including timely reporting of safety information

Qualifications & Experience

Essential

• Degree in Pharmacy (Certified Pharmacist)
• Minimum 1 year experience as a Responsible Person
• Strong understanding of GDP requirements
• Experience in pharmaceutical quality systems (QA GMP/GDP)
• Fluent English (professional / negotiation level)
• Valid driving licence

Preferred

• 15 years experience in GDP environment
• Experience in GMP

Why Join AstraZeneca

• Work in a highly regulated high-impact quality role
• Be part of a global science-led biopharmaceutical company
• Contribute to ensuring the safety and quality of medicines for patients
• Collaborate with international and cross-functional teams

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.