GDP Quality Coordinator

GDP, gyógyszer nagykereskedelem, minőségbiztosítás, gyógyszerész, vegyész

Your new company

We are looking for an experienced QA specialist (GDP background) for our multinational pharmaceutical partner, to remotely support the company’s Swiss operations from Hungary.

Your new role

  • Support the QP of the company’s Swiss counterpart in maintaining their GDP/GMP license.
  • Support maintenance of the Quality Systems which ensure compliance to the EU regulations as well as to the Swiss Legislation.
  • Initiate and manage Complaints, Change Controls, Deviations for products of the company’s Swiss counterpart.
  • Support Global Operations Auditing audits and Swiss Medic inspections of the company’s Swiss counterpart and participate in local Health Authority inspections and audits in regards to the activities of the company’s Swiss counterpart.
  • Ensure GDP/GMP compliance and audit status of all service providers in connection with Global Quality.
  • Support product recall processes.
  • Provide KPI data for the Quality Management Review and for the Quality Metrics.
  • Support maintenance of Quality Technical Agreements with Suppliers, Contractors/Service Providers or customers of the company’s Swiss counterpart
  • Support Supplier Management and Bona fides check of customers activities of the company’s Swiss counterpart (including but not limited to contract warehouses)
  • Work in close collaboration with Regional Supply Chain, Master Data, Distribution teams and Affiliates in order to deliver inputs in compliance with GDP requirements.
  • Support management of returned goods.
  • Support maintenance of written procedures of the company’s Swiss counterpart.
  • Perform QA transactions and necessary quality checks in SAP to support the QP/RP activities of the company’s Swiss counterpart.
  • Responsible for quality assurance liaison with external warehouses and transportation companies working on behalf of the company’s Swiss counterpart, including management of quality issues.
  • Provide GDP support to affiliates.
  • Support in projects.
  • Support in training activities and in training documentation.
  • Keep their knowledge up-to-date
  • Carry out other duties as assigned by the QP of the company’s Swiss counterpart and by their manager.

What you’ll need to succeed

  • BSc/MSc degree in a LifeSciences discipline; PharmD degree is a great asset
  • Solid knowledge of GDP: at least 6 months’ experience in such a setup, in quality assurance
  • Fluent English skills + Hungarian native (daily usage of both, spoken & written)
  • Attention to details, accuracy; strong writing skills (SOPs and other documents); able to make decisions independently

What you’ll get in return

  • diverse package (rental contribution, 100% travel reimbursement, free lunch option on site, cafeteria, insurance, health screenings)
  • stable and growing quality centre in the region
  • career opportunities

What you need to do now
If you have the required professional background and interested in this role, click on the „Apply” button.

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Job Type
Komárom-Esztergom megye
Life Sciences

Talk to a consultant

Talk to Altmann Vivien, the specialist consultant managing this position, located in Budapest
Budapest, Szabadság tér 7, Bank Center

Telephone: 36703802102