Key Responsibilities:
The Responsible Person - Consumer Healthcare (CHC) will manage the implementation and maintenance of the CHC Hungarian Affiliate Quality System, ensuring compliance with GxP regulatory requirements, Global Quality standards, and national EU legislation.
This role includes overseeing/supervision Good Distribution Practice of medicinal products for human use and Medical Devices.
Key responsibilities include:
- Implementing and maintaining a quality management system for various health-regulated products.
- Managing authorized activities, ensuring accuracy and quality of records.
- Ensuring and maintaining training programs.
- Coordinating recall operations for various products.
- Handling customer complaints effectively.
- Approving suppliers, customers, and subcontracted activities impacting GDP.
- Conducting regular self-inspections and implementing corrective measures.
- Deciding on the final disposition of returned, rejected, recalled, or potentially falsified products.
- Ensuring adherence to national law requirements.
- Overseeing the management and documentation of the QMS Medical Devices.
- Managing document management system
- Proactively participates to achieve Site Quality Risk Assessment, in developing and implementing the Organization Quality Plan
- Proactively participates under the guidance of Country Quality Head to local implementation of Global policy / guidelines / standards / procedures from Quality Manual
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Scope and Role Impact:
- Cross-functional management within the CHC Hungary Affiliate.
- Key role in ensuring consistent application of Quality requirements.
Required Skills and Experience:
Educational Qualifications: Candidates must hold a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in pharmacy, medicine.
Experience: Candidates should have significant experience in the Good Distribution Practice (GDP) domain within an affiliate setting, demonstrating a thorough understanding of the specific challenges and requirements of this area. More than 1 year experience as in performing the functions of a Responsible Person on a WDA.
Knowledge:
- Advanced understanding of GxP, Quality risk analysis and management, Regulatory requirements.
- Familiarity with EU Good Distribution Practice
- Experience in Quality Systems
- Life-cycle Management
- Veeva Quality knowledge will be considered as a plus.
- Ability to act for change, commit to customers
- Very good communication skills, negotiation, and problem-solving skills.
- Languages:English - fluent, Hungarian language knowledge is mandatory for the position.
When joining our team, you will experience:
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
- An attractive, market-oriented salary and cafeteria benefits
- Collective life and accident insurance
- Yearly medical check-up
- An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
- Your own career path within Sanofi. Your professional and personal development will be supported purposefully
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