Hozzáadott 1 week ago
Country Quality Head & Responsible Person - Hungary
Munkavégzés helyeBUDAPEST, Budapest, Hungary PP Adecco
Foglalkoztatás jellegeManager
Dátum2024-12-03
KategóriaQuality
Country Quality Head & Responsible Person - Hungary
Country Quality Head & Responsible Person
Why should you join:
- Competitive wages
- Flexible Home Office opportunities- (50%)
- Company car
- Yearly bonus
- Cafeteria
- Yearly medical check-up
- Excellent working conditions
- Great atmosphere with an international professional team
- Individual Development
- Opportunity to use your language skills
- Well-structured and employee friendly On-boarding
What will you do:
- Oversee the implementation and maintenance of the Quality System for regulated healthcare products.
- Ensure the accuracy and quality of records related to authorized operations.
- Develop and manage comprehensive GxP training programs to maintain compliance.
- Coordinate and execute product recall operations efficiently.
- Address customer complaints, perform trend analysis, and implement improvements.
- Approve suppliers, customers, and subcontracted activities to ensure GDP compliance.
- Conduct routine self-inspections, identify deficiencies, and implement corrective actions.
- Ensure any deficiency or change is managed properly, quality risk is assessed and action plan is in place and followed up.
- Maintain and oversee records of delegated responsibilities and ensure their effective management.
- Decide on the final disposition of returned, rejected, recalled, or potentially falsified products.
- Ensure compliance with all national regulatory requirements and standards.
- Manage and document the quality management system (QMS) for Medical Devices.
- Serve as a Quality Business Partner, collaborating across functions to align with business goals.
- Ensure adherence to the GxP subcontractor audit plan and its successful execution.
- Manage and support regulatory GxP inspections at the Affiliate level.
- Act as the primary liaison for Competent Authorities on quality-related matters.
- Serve as the Responsible Person, ensuring GDP compliance in storage and distribution processes within the marketplace.
Join if you have:
- Experience in Quality Systems, and Product Life-cycle Management
- University degree - Pharmacist diploma.
- Meets local regulations for nomination of Responsible Person
- Significant experience in the Good Distribution Practice (GDP) domain
- Fluency in English and in Hungarian
- Strong leadership, communication, negotiation, and problem-solving skills.
- Ability to act for change, commit to customers, and lead teams strategically.
- Knowledge & experience in Medical, Regulatory, Clinical or in Pharmacovigilance domain will be appreciated
Location: Budapest
Legutóbbi kereséseim
- BUDAPEST, Budapest, Hungary PP Adecco
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- PEST, BUDAPEST, Hungary Staffing Adecco
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- FEJÉR, Székesfehérvár, Hungary Staffing Adecco
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