GDP Quality Responsible Person for Hungarian market
GDP Quality Responsible Person for Hungarian market
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Job Description
Job Description
Are you passionate about ensuring the highest standards in pharmaceutical distribution Join our team as a Senior Quality Assurance Specialist (GDP Quality Responsible Person for Hungarian market) and play a pivotal role in safeguarding product quality enabling patient access to our products and ensuring GDP compliance across Hungary operation.
About the Role
As the Quality Responsible Person you will be the cornerstone of our quality assurance efforts ensuring that the distribution of our products within Hungary meets all Good Distribution Practice (GDP) standards regulatory and requirements. You will oversee the local Quality Management System maintain compliance and drive continuous improvement in all quality-related activities.
Based in our Budapest officewith flexible options to work from homeyou will collaborate closely with colleagues from Customer Service Regulatory Affairs and Quality Assurance teams both locally and at our distribution center. You will report directly to the Central East Europe In-market QA Lead who will support your onboarding and professional growth.
We are offering Fixed-term position for 15 years.
Key Responsibilities
- Product Release & Distribution: Oversee and authorize the release of products for distribution in Hungary working closely with our regional warehouse Quality Responsible Person.
- Compliance & Quality Management: Ensure all distribution activities comply with GDP local and EU regulations. Maintain and continuously improve the local Quality Management System including document management deviation tracking CAPAs change controls risk assessments and self-inspections.
- Internal & External Collaboration: Serve as the primary contact for Health Authority interactions and notifications related to quality tasks. Communicate effectively with internal departments service providers and external agencies.
- Audit & Inspection Management: Lead and support audits and inspections.
- Training & Development: Maintain the local training system develop and deliver GDP-relevant trainings to employees and manage training documentation.
- Incident & Complaint Handling: Assess temperature excursions manage product quality complaints and report suspected counterfeit diversion or tampering cases.
- Continuous Improvement: Support local and regional projects related to compliance business initiatives and company-wide quality initiatives.
- Recall Coordination: Lead local coordination and execution of recalls and mock recalls.
- Data Integrity: Ensure Data Integrity principles are applied to all GxP-relevant activities.
What Were Looking For
- Education: Degree in Pharmacy (Hungary)
- Experience: Minimum 1 year in a Quality role within the pharmaceutical sector with hands-on experience in GDP to be qualified as Quality Responsible Person for our WDA.
- Regulatory Knowledge: Strong understanding of local and EU requirements for pharmaceutical distribution and storage
- Technical Skills: Experience with Document Management Systems is a plus; strong data analysis and risk assessment abilities
- Communication: Proficient in both English and Hungarian (written and spoken); able to clearly communicate scientific and logistics topics
- Personal Qualities: Strategic thinker with a hands-on approach high work capacity and a collaborative mindset
Why Join Us
- Impact: Play a vital role in ensuring the safety and quality of medicines distributed across Hungary.
- Growth: Benefit from strong onboarding support and be part of diverse local and regional projects to expand your QA expertise.
- Collaboration: Be part of a supportive cross-functional team committed to excellence.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
Project Temps (Fixed Term)Relocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Audit Inspections Audit Inspections Business Initiatives cGMP Regulations Change Management Complaint Resolutions Customs Regulations Deviation Management Distribution Management Document Management EU Regulations Good Automated Manufacturing Practice (GAMP) Good Distribution Practice (GDP) Government Affairs Herbal Medicines Import Export Compliance Inspection Management System Managing Distribution Channels Manufacturing Compliance Manufacturing Quality Control Pharmaceutical Quality Assurance Prescription Dispensing Quality Assurance (QA) Standards Quality Auditing Quality Management Standards 1 morePreferred Skills:
Job Posting End Date:
08/29/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Employment Type
Full-Time
