MSD Senior Specialist Quality Assurance 

Hungary 

224391378

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.

Quality Responsible Personis 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 assessment
• Ensure 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 documents
• Notify 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 Hungary
• Relevant 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 storage
• Experience working with Document Management Systems would be a plus
• Ability to understand and clearly communicate scientific and logistics topics
• Strong data analytical skills
• Ability to combine strategic vision with tactical hand-on execution and a high work capacity
• Ability to analyze information and assess risk potential
• Proficient in English and Hungarian (written & spoken)

Current Contingent Workers apply

Project Temps (Fixed Term)

Not Applicable

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

Job Posting End Date:08/04/2024

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.