SGP
3 days ago
QA Intern, Documentation and Data Integrity
**Job Title:** QA Intern, Documentation and Data Integrity **About the Job:** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. **Main Responsibilities:** The Quality Systems (QS) sub-team is under the remit of the Site Quality Department and is responsible for the quality system management (QMS) implementation within the site. The QS sub-team is responsible for setting up or reviewing and auditing the quality management systems to be used by the entire site, which is instrumental in ensuring the site systems and processes meet the international GxP requirements. The Data Integrity Program is key to ensure the compliance use of the digital initiatives. This includes working closely with the respective functional teams to provide oversight and guidance for data integrity and projects related to data integrity to achieve the site’s digital ambition while in compliance with data integrity requirements. Another aspect is to manage Quality Culture program, enabling the right Quality Culture to be embedded onsite. **About You:** New project for Documentation Management System: + Support the implementation of digital documentation solutions like electronic logbooks and manage the GMP governance and issuance of paper-bound logbooks on site. + Support the implementation of digital documentation solutions like electronic forms and manage the GMP governance and issuance of controlled printing of forms on site. + Lead and implement framework and solution for document archival and destruction process on site. + Set up site document archive room. Quality Culture Program/ Data Integrity : + Support in the development and roll out the Quality Culture program onsite + Tracking of Quality gaps and near misses, with the use of data visualization tool to communicate stakeholders + Status tracking of identified actions in Data Integrity Plan **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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