MSD Quality Assurance Senior Specialist 

Hungary 

610747561

Job Description

Key Responsibilities:

• Ensure compliance with GDP across all aspects of transportation (inbound and outbound), storage, product handling, documentation, and archiving.
• Support compliance efforts of third-party logistics provider (UPS Healthcare Hungary) with GDP, local, and EU regulatory requirements, specifically in alignment with our Quality Technical Agreement.
• Oversee adherence to regulations relating to Quality and Compliance for the distribution and wholesaling of products across the market.
• Release products for distribution to the Hungarian market, in close cooperation with our Company Hungary Quality Responsible Person (QRP) and for exports to other Central and Eastern European (CEE) markets.
• Communicate effectively and provide support to internal departments, service providers, agencies, and representatives of target markets.
• Manage audits/inspections and product recalls, ensuring readiness and compliance.
• Write and review procedures with GDP impact, ensuring they are up-to-date and effective.
• Manage, document, and monitor deviations, Corrective and Preventive Actions (CAPA), and change control processes, alongside supporting risk assessments.
• Ensure thorough validation of facilities, equipment, and systems, verifying results meet required standards.
• Maintain communication with Health Authorities, local business units, and regional Quality Management regarding Quality issues.
• Develop, implement, and maintain a robust local Quality Management System while ensuring alignment with management priorities and effective handling of relevant topics.
• Maintain the Document Management System and the local training system, including managing and tracking training documents while conducting GDP employee training.
• Notify the DPOC of target countries regarding Product Quality complaints and suspected Counterfeit, Diversion, or Tampering cases.
• Assess temperature excursions that occur under our Company’s ownership.
• Collaborate closely with Distribution & Logistics and the third-party logistics provider to ensure seamless operations.
• Support Regional Distribution Center Quality Oversight in compliance-related activities across other centers.

Qualifications:

• Education: Degree in Pharmacy or related discipline from a recognized institution in Hungary.
• Experience: Minimum of 1-year relevant experience in Quality positions (Good Distribution Practice) within the pharmaceutical sector in Hungary.
• Knowledge: Strong understanding of local and EU regulatory requirements concerning transportation and storage.
• Skills:
  • Familiarity with Document Management Systems is a plus.
  • Excellent communication skills with the ability to convey scientific and logistics concepts clearly.
  • Strong data analytical skills and capability to assess risk potential effectively.
  • Ability to blend strategic vision with hands-on execution, demonstrating high work capacity.
  • Proficiency in both English and Hungarian (written and spoken).

What We Offer:

• Competitive salary and benefits package.
• Opportunities for personal and professional development.
• A dynamic work environment where you can make a significant impact.
• Supportive and collaborative team culture.

Application Process:

If you are ready to contribute to a leading organization committed to quality and compliance in the pharmaceutical industry, please submit your application detailing your relevant experience.

Current Contingent Workers apply

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