Job Description

Reporting to the Regional Distribution Center Quality Lead you will partner with colleagues cross functionally to provide support and advice on a day-to-day basis.

The Quality Responsible Person is supporting in maintaining documents in the Document Management System, tracking and monitoring deviations, CAPAs, change controls, PQCs and maintaining spreadsheets, risk assessments and self-inspections.

The key tasks of your role will be:

Ensure compliance with GDP of: Transportation (in- and outbound); Storage and product handling; Documentation and archiving; Secondary repackaging.Support on ensuring that third-party logistics provider (UPS Healthcare Hungary) complies with GDP, local and EU regulatory requirements, and aligns with our Company IS – UPS Quality Technical Agreement.Ensure that regulations relating to Quality and Compliance for distribution and wholesaling of products on the market (GDP) are fulfilled.Release products for distribution to the Hungarian market with close cooperation of our Company Hungary QRP and export to other CEE markets.Communicate with and support internal departments, service providers, agencies, and representatives of target markets.Manage audits/inspections, recalls.Write & review procedures with GDP impact.Manage, document, and monitor deviation, CAPA, change control, support risk assessmentEnsure facility, equipment, system validation is performed, and results meet requirements.Communication with Health Authority, local business and regional Quality Management interactions and notifications regarding Quality issues.Develop, implement, and maintain the local Quality Management System. As part of this, ensure that local management is aware of and aligned with key priorities, and that relevant topics are discussed and handled together, as appropriate.Maintaining the Document Management System.Maintaining the local training system and carry out GDP employee trainings. Manage and track training documentsNotify DPOC of target country about Product Quality complaints and suspected Counterfeit, Diversion or Tampering cases.Assessment of temperature excursions that occurred under our Company IS ownership.Close collaboration with Distribution & Logistics and the third-party logistics provider.Support the RDC Quality Oversight in other Regional Distribution Centers in activities related to compliance to GDP and our Company requirements.

You should apply if you have:

Degree educated in Pharmacy discipline in HungaryRelevant experience in Quality positions (Good Distribution Practice) in the pharmaceutical sector in Hungary (1 year experience as minimum requirement)Excellent understanding of local and EU regulatory requirements of transportation and storageExperience working with Document Management Systems would be a plusAbility to understand and clearly communicate scientific and logistics topicsStrong data analytical skillsAbility to combine strategic vision with tactical hand-on execution and a high work capacityAbility to analyze information and assess risk potentialProficient in English and Hungarian (written & spoken)

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Audit Management, cGMP Regulations, Change Management, Deviation Management, Document Management, Electronic Document Management System (EDMS), Good Automated Manufacturing Practice (GAMP), Management Process, Manufacturing Compliance, Manufacturing Quality Control, Organizational Performance Management, Pharmaceutical Quality Assurance, Product Disposition, Quality Assurance (QA), Quality Auditing, Quality Management Standards, Quality Management System Improvement, Quality Standards, Regulatory Compliance, Regulatory Requirements, Risk Management, Self Motivation, Social Collaboration {+ 3 more}

 Preferred Skills:

Job Posting End Date:

07/15/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R354159