Regional Quality Documentation Specialist
Budapest, Hungary Permanent Date posted Oct. 25, 2024- Location: Budapest
About the job
Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.
As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.
The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.
Main responsibilities:
- With a focus on initiation of quality documents (QD) deliverables
- Create DocID in QualiPSO and metadata: manage the creation & update of metadata
- Implement updates of applicability of the documents and stakeholders, update picklist (e.g. material, buildings, etc.)
- Implement communication strategy based on local document governance
- Coordinate transversal Content Management System (CMS) QualiPSO administration – check user access and privilege (care request management), training assignment and annual review access
- Support good documentation practices training and communication
- Support document change request (DCR) process – Support monitoring of DCR process including KPI, DCR sharing for decision (to author and local Doc Controllers)
- Support periodic review by monitoring periodic revision process with KPI, interaction with Author/local Doc Controllers, launch of periodic revision process in the tool
About you
Experience:
- Approximately 1 year of professional experience in documentation, in GxP environment
Soft and technical skills:
- Proficient in problem-solving, attention to detail, and good organizational skills
- Ability to work collaboratively with cross-functional teams in a flexible and proactive manner
- Strong analytical skills
- Agile thinker and learner, adaptable to complex & dynamic environments
- Strong skills in Quality DMS, Word, Excel, PowerPoint
Education: Minimum bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field
Languages: Excellent written and verbal communication skills in English
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
- Work from an "Office of the Year 2023" award winner with flexible home office policy
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
- 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
- Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)
PursueProgress. Discover Extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN videoand check out our Diversity Equity and Inclusion actions at sanofi.com!
Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.
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Pursue progress. Discover extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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Experience possibility
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