Quality Assurance - Manager
Sanofi
- Budapest
- Állandó
- Teljes munkaidő
- 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
- Cross-functional management within the CHC Hungary Affiliate.
- Key role in ensuring consistent application of Quality requirements.
- 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, chemistry, medicine, biology, or a related life science.
- 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:
- Technical/Professional:
- Experience in Quality Systems,
- Continuous Improvement
- Life-cycle Management
- Veeva Quality knowledge will be considered as a plus.
- Computer literacy
- Soft Skills:
- Very good communication skills, negotiation, and problem-solving skills.
- Ability to act for change, commit to customers
- This role will be based 100% in Office in Budapest
- Languages: English - advanced
- 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
- Practice your language skills within our "Language Club"
- Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)
- 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
- Practice your language skills within our "Language Club"
- Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)