Job Description

Are you a detail-oriented professional passionate about ensuring quality and compliance in the pharmaceutical sector? If so, we invite you to apply for the position of Quality Responsible Person at our Regional Distribution Center. This is an exciting opportunity to partner cross-functionally and play a critical role in maintaining the highest standards of Good Distribution Practice (GDP).

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.

Apply Now!

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):

Job Posting End Date:
12/15/2024

• 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.
  

Requisition ID:R324575