QA Manager- Responsible person

Location: Budapest, Hungary

Company: Amgen Hungary

Position Overview: We are seeking a highly qualified and dedicated Quality Manager & Responsible Pharmacist to join our Budapest office. This key role is responsible for ensuring the strict adherence to EU Good Distribution Practice (GDP) requirements and Hungarian regulations related to wholesale distribution. The successful candidate will oversee all quality-related aspects of Amgen products in the Hungarian market and manage the implementation of the Quality Management System (QMS) in compliance with local regulations and Amgen’s global standards.

Key Responsibilities:

• Responsible Pharmacist Duties:

  • Act as the Responsible Pharmacist (RP) for Amgen Hungary’s pharmaceutical warehouse.
  • Supervise the qualification, storage, and recall/withdrawal of medicinal products, ensuring compliance with Schedule 2 of the 53/2004 MoHSF Decree.
  • Oversee the release of products to the Hungarian market, ensuring compliance with all relevant regulations.
  • Be present at every replenishment arrival to supervise processes.
  • Manage and follow up on product complaints.
  • Maintain and continually improve the Quality Management System (QMS) in adherence with Hungarian regulatory requirements and Amgen procedures.
  • Keep up-to-date with EU and Hungarian regulations, translate them into actionable steps, and communicate updates through Amgen’s GMP Intelligence program.

• Quality Management:

  • Host authority inspections and internal audits, ensuring all quality standards are met.
  • Maintain a productive relationship with the local Hungarian team, IDQ team members, Supply Chain colleagues, and warehouse staff.
  • Provide support in troubleshooting unit operations, resolving GDP-related investigations, and documenting findings.
  • Conduct risk assessments, change control, and qualification of pharmaceutical equipment.

• Collaboration & Communication:

  • Interact effectively with cross-functional teams, adapting to a variety of communication and working styles.
  • Utilize strong problem-solving skills to assess data and make decisions related to compliance and product quality.
  • Communicate effectively both verbally and in writing in Hungarian and English.

Qualifications:

• Educational Background:

  • Degree in Pharmacy and qualifications as a Responsible Pharmacist (RP).

• Experience:

  • Minimum of 3 years of experience as a Responsible Pharmacist within an innovative pharmaceutical company, preferably with biologics or vaccines.
  • Extensive knowledge of Hungarian regulations related to distribution, the European Pharmaceutical Directive on Distribution of Medicinal Products, Good Distribution Practice (GDP), and Good Manufacturing Practices (GMP).
  • Experience with cold chain transportation and storage, and local regulatory requirements.
  • Proven experience in regulatory inspections, pharmaceutical equipment qualification, risk assessments, and change control.
  • Experience in providing support, troubleshooting unit operations, and resolving GDP-related issues.

• Skills:

  • Fluency in both Hungarian and English.
  • Strong technical writing skills, with the ability to communicate complex concepts clearly and effectively.
  • Excellent problem-solving abilities with a logical approach to data assessment.
  • Strong interpersonal skills to interact effectively with cross-functional teams.

Travel Requirements:

• Up to 5% travel may be required for meetings and training.

Application Process: Interested candidates who meet the above requirements are encouraged to apply by submitting their resume and a cover letter outlining their qualifications and experience relevant to this role.